Upload
others
View
2
Download
0
Embed Size (px)
Citation preview
20 CAPSULES
Actual SizeN
r
Do not use if printed safety seal under cap istorn or m
issing.
r ecu
deRr
eveF
/rev
eileR
niaP
mui d
oSne
xor p
aNg
m02
2,se
l usp
aC) D
I ASN
(
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 m
g (NSAID)
Strength to last 12 hours
NDC 69452-179-11
Lot No :
Exp. Date:
r Sr S SAID) 20 C AP SU LE S
Actual Size
Manufactured for:
BIONPHARMA 600 Alexander Road, Princeton, NJ 08540
R0220 L0000000
Drug Facts (continued) Do not use O if you have ever had an allergic reaction to any other pain reliever fever reducer O right before or after heart surgery Ask a doctor before use if O stomach bleeding warning applies to you O you have a history of stomach problems, such as heartburn O you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke O you are taking a diuretic O you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are O under a doctor's care for any serious condition O taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin O taking any other drug When using this product O take with food or milk if stomach upset occurs Stop use and ask a doctor if O you experience any of the fo lowing signs of stomach
bleeding: O feel faint O vomit blood O have bloody or black stools O have stomach pain that does not get better O you have symptoms of heart problems or stroke:
Drug Facts (continued) f pregnant or breast-feeding, ask a hea th professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions O do not take more than directed O the smallest effective dose should be used O drink a full glass of water with each dose O if taken with food, this product may take longer to work
Other information O each capsule contains: sodium 20 mg O store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F). O Protect from light. O read a l directions and warnings before use. Keep carton.
Inactive ingredients FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
O take 1 capsule every 8 to 12 hours while symptoms last
O for the first dose you may take 2 capsules within the first hour
O do not exceed 2 capsules in any 8- to 12-hour period
O do not exceed 3 capsules in a 24-hour period
adults and children 12 years and older:
children under 12 years: O ask a doctor
O chest pain O trouble breathing O weakness in one part or side of body O slurred speech O leg swelling O pain gets worse or lasts more than 10 days O fever gets worse or lasts more than 3 days O redness or swe ling is present in the painful area O any new symptoms appear O you have difficulty swallowing O it feels like the capsule is stuck in your throat
Questions or comments? 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)
Drug Facts Active ingredient (in each capsule) Purposes Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* ..... Pain reliever fever reducer *nonsteroidal anti-inflammatory drug
Uses O temporarily relieves minor aches and pains due to: O minor pain of arthritis O muscular aches O backache O menstrual cramps O headache O toothache O the common cold O temporarily reduces fever
WarningsAllergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: O hives O facial swe ling O asthma (wheezing) O shock O skin reddening O rash O blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSA D, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or older O have had stomach ulcers or bleeding problems O take a blood thinning (anticoagulant) or steroid drug O take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) O have 3 or more alcoholic drinks every day while using this product O take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
BIONPHARMA
Labeling Format Information:
Fonts: Helvetica Condensed Bold, Helvetica Condensed, Helvetica Condensed Bold Oblique
Drug Facts: 8pt Header: 7pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): 7pt
Horizontal Scale: 100% Average Kerning: 0%
Leading: 6.5pt Bullets: 5pt Barlines: 7pt Hairlines: .5pt
Reference ID: 4601010
20 CAPSULES
Actual SizeN
r
Do not use if printed safety seal under cap istorn or m
issing.
r ecu
deRr
eveF
/rev
eileR
niaP
mui d
oSne
xor p
aNg
m02
2,se
l usp
aC) D
I ASN
(
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 m
g (NSAID)
Strength to last 12 hours
NDC 69452-179-11
Lot No :
Exp. Date:
r Sr S SAID) 20 C AP SU LE S
Actual Size
Manufactured for:
BIONPHARMA 600 Alexander Road, Princeton, NJ 08540
R0220 L0000000
Drug Facts (continued) Do not use O if you have ever had an allergic reaction to any other pain reliever fever reducer O right before or after heart surgery Ask a doctor before use if O stomach bleeding warning applies to you O you have a history of stomach problems, such as heartburn O you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke O you are taking a diuretic O you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are O under a doctor's care for any serious condition O taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin O taking any other drug When using this product O take with food or milk if stomach upset occurs Stop use and ask a doctor if O you experience any of the fo lowing signs of stomach
bleeding: O feel faint O vomit blood O have bloody or black stools O have stomach pain that does not get better O you have symptoms of heart problems or stroke:
Drug Facts (continued) f pregnant or breast-feeding, ask a hea th professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions O do not take more than directed O the smallest effective dose should be used O drink a full glass of water with each dose O if taken with food, this product may take longer to work
Other information O each capsule contains: sodium 20 mg O store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F). O Protect from light. O read a l directions and warnings before use. Keep carton.
Inactive ingredients FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
O take 1 capsule every 8 to 12 hours while symptoms last
O for the first dose you may take 2 capsules within the first hour
O do not exceed 2 capsules in any 8- to 12-hour period
O do not exceed 3 capsules in a 24-hour period
adults and children 12 years and older:
children under 12 years: O ask a doctor
O chest pain O trouble breathing O weakness in one part or side of body O slurred speech O leg swelling O pain gets worse or lasts more than 10 days O fever gets worse or lasts more than 3 days O redness or swe ling is present in the painful area O any new symptoms appear O you have difficulty swallowing O it feels like the capsule is stuck in your throat
Questions or comments? 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)
Compare to the active ingredient
of ALEVE ® Liquid Gels***
***This product is not manufactured or distributed by the owners of ALEVE® Liquid Gels.
Drug Facts Active ingredient (in each capsule) Purposes Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* ..... Pain reliever fever reducer *nonsteroidal anti-inflammatory drug
Uses O temporarily relieves minor aches and pains due to: O minor pain of arthritis O muscular aches O backache O menstrual cramps O headache O toothache O the common cold O temporarily reduces fever
WarningsAllergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: O hives O facial swe ling O asthma (wheezing) O shock O skin reddening O rash O blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSA D, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or older O have had stomach ulcers or bleeding problems O take a blood thinning (anticoagulant) or steroid drug O take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) O have 3 or more alcoholic drinks every day while using this product O take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
BIONPHARMA
Labeling Format Information:
Fonts: Helvetica Condensed Bold, Helvetica Condensed, Helvetica Condensed Bold Oblique
Drug Facts: 8pt Header: 7pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): 7pt
Horizontal Scale: 100% Average Kerning: 0%
Leading: 6.5pt Bullets: 5pt Barlines: 7pt Hairlines: .5pt
Reference ID: 4601010
30 CAPSULES
Actual Size
SSAID)))
Do not use if printed safety seal under cap istorn or m
issing.
r ecu
deRr
eveF
/rev
eileR
niaP
mui d
oSne
xor p
aNg
m02
2,se
l usp
aC) D
I ASN
(
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 m
g (NSAID)
Strength to last 12 hours
NDC 69452-179-13
Lot No :
Exp. Date:
A SAID) 30 C AP SU LE S
Actual Size
Manufactured for:
BIONPHARMA 600 A exander Road, Princeton, NJ 08540
Do not use O if you have ever had an allergic reaction to any other pain re iever/fever reducer O right before or after heart surgery Ask a doctor before use f O stomach bleeding warning applies to you O you have a history of stomach problems, such as heartburn O you have high blood pressure, heart disease, liver cirrhosis,
kidney disease, asthma, or had a stroke O you are taking a diuretic O you have prob ems or serious side effects from taking pain
relievers or fever reducers
Drug Facts (continued)
Ask a doctor or pharmacist before use f you are O under a doctor's care for any serious condition O taking aspirin for heart a tack or stroke, because naproxen
may decrease this benefit of aspirin O taking any other drug When using this product O take with food or milk if stomach upset occurs Stop use and ask a doctor if O you experience any of the fol owing signs of stomach
bleeding: O feel faint O vomit blood O have b oody or black stoo s O have stomach pain that does not get better O you have symptoms of heart problems or stroke: O chest pain O troub e breathing O weakness in one part or side of body O slurred speech O eg swe ling O pain gets worse or lasts more than 0 days O fever gets worse or lasts more than 3 days O redness or swe ling is present in the painful area O any new symptoms appear O you have di ficu ty swa lowing O it feels like the capsule is stuck in your throat
f pregnant or breast feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during de ivery. Keep out of reach of children. In case of overdose, get medical he p or contact a Poison Control Center right away.
Directions O do not take more than directed O he sma lest effective dose should be used O drink a full glass of water with each dose O if taken with food, this product may take onger to work
Drug Facts (cont nued)
Other information O each capsule contains: sodium 20 mg O store at 20-25°C (68-77°F) avoid high humidity and
excessive heat above 40°C (104°F). O Protect from ight. O read all directions and warnings before use. Keep carton.
Inactive ingredients FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethy ene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Questions or comments? 1 888 235 2466 (Mon - Fri 9AM - 5PM EST)
O take 1 capsule every 8 to 2 hours whi e symptoms last
O for the first dose you may take 2 capsules within the first hour
O do not exceed 2 capsules in any 8- to 12-hour period
O do not exceed 3 capsu es in a 24-hour period
adults and chi dren 2 years and o der:
children under 2 years: O ask a doctor
R0220 L0000000
Drug Facts Active ingredient (in each capsule) Purposes Naproxen sodium 220 mg (naproxen 200 mg (NSAID)*.. ... .. .. Pain re iever/fever reducer *nonsteroidal anti-inflammatory drug
Uses O temporarily re ieves minor aches and pains due to: O minor pain of arthritis O muscular aches O backache O menstrual cramps O headache O toothache O the common co d
O temporarily reduces fever
Warnings Allergy alert: Naproxen sodium may cause a severe a lergic reaction, especially in people allergic to aspirin. Symptoms may include: O hives O facial swe ling O asthma (wheezing) O shock O skin reddening O rash O blisters If an al ergic reaction occurs, stop use and seek medical he p right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or older O have had stomach ulcers or b eeding prob ems O take a b ood thinning (anticoagulant) or steroid drug O take other drugs containing prescription or nonprescription
NSAIDs (aspirin, ibuprofen, naproxen, or others) O have 3 or more a coholic drinks every day while using
this product O take more or for a onger time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart a tack, heart fai ure, and stroke. These can be fatal. The risk is higher if you use more than directed or for onger than directed.
BIONPHARMA
Labeling Format Information:
Fonts: Helvetica Condensed Bold, Helvetica Condensed, Helvetica Condensed Bold Oblique
Drug Facts: 8pt Header: 7pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): 7pt
Horizontal Scale: 100% Average Kerning: 0%
Leading: 7.2pt Bullets: 5pt Barlines: .6pt Hairlines: .2pt
Reference ID: 4601010
30 CAPSULES
Actual Size
SSAID)))
Do not use if printed safety seal under cap istorn or m
issing.
r ecu
deRr
eveF
/rev
eileR
niaP
mui d
oSne
xor p
aNg
m02
2,se
l usp
aC) D
I ASN
(
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 m
g (NSAID)
Strength to last 12 hours
NDC 69452-179-13
Lot No :
Exp. Date:
A SAID) 30 C AP SU LE S
Actual Size
Manufactured for:
BIONPHARMA 600 A exander Road, Princeton, NJ 08540
Do not use O if you have ever had an allergic reaction to any other pain re iever/fever reducer O right before or after heart surgery Ask a doctor before use f O stomach bleeding warning applies to you O you have a history of stomach problems, such as heartburn O you have high blood pressure, heart disease, liver cirrhosis,
kidney disease, asthma, or had a stroke O you are taking a diuretic O you have prob ems or serious side effects from taking pain
relievers or fever reducers
Drug Facts (continued)
Ask a doctor or pharmacist before use f you are O under a doctor's care for any serious condition O taking aspirin for heart a tack or stroke, because naproxen
may decrease this benefit of aspirin O taking any other drug When using this product O take with food or milk if stomach upset occurs Stop use and ask a doctor if O you experience any of the fol owing signs of stomach
bleeding: O feel faint O vomit blood O have b oody or black stoo s O have stomach pain that does not get better O you have symptoms of heart problems or stroke: O chest pain O troub e breathing O weakness in one part or side of body O slurred speech O eg swe ling O pain gets worse or lasts more than 0 days O fever gets worse or lasts more than 3 days O redness or swe ling is present in the painful area O any new symptoms appear O you have di ficu ty swa lowing O it feels like the capsule is stuck in your throat
f pregnant or breast feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during de ivery. Keep out of reach of children. In case of overdose, get medical he p or contact a Poison Control Center right away.
Directions O do not take more than directed O he sma lest effective dose should be used O drink a full glass of water with each dose O if taken with food, this product may take onger to work
Drug Facts (cont nued)
Other information O each capsule contains: sodium 20 mg O store at 20-25°C (68-77°F) avoid high humidity and
excessive heat above 40°C (104°F). O Protect from ight. O read all directions and warnings before use. Keep carton.
Inactive ingredients FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethy ene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Questions or comments? 1 888 235 2466 (Mon - Fri 9AM - 5PM EST)
O take 1 capsule every 8 to 2 hours whi e symptoms last
O for the first dose you may take 2 capsules within the first hour
O do not exceed 2 capsules in any 8- to 12-hour period
O do not exceed 3 capsu es in a 24-hour period
adults and chi dren 2 years and o der:
children under 2 years: O ask a doctor
R0220 L0000000
***This product s not manufactured or distributed by the owners of ALEVE® Liqu d Gels.
Compare to the active ingredient
of ALEVE ® Liquid Gels***
Drug Facts Active ingredient (in each capsule) Purposes Naproxen sodium 220 mg (naproxen 200 mg (NSAID)*.. ... .. .. Pain re iever/fever reducer *nonsteroidal anti-inflammatory drug
Uses O temporarily re ieves minor aches and pains due to: O minor pain of arthritis O muscular aches O backache O menstrual cramps O headache O toothache O the common co d
O temporarily reduces fever
Warnings Allergy alert: Naproxen sodium may cause a severe a lergic reaction, especially in people allergic to aspirin. Symptoms may include: O hives O facial swe ling O asthma (wheezing) O shock O skin reddening O rash O blisters If an al ergic reaction occurs, stop use and seek medical he p right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or older O have had stomach ulcers or b eeding prob ems O take a b ood thinning (anticoagulant) or steroid drug O take other drugs containing prescription or nonprescription
NSAIDs (aspirin, ibuprofen, naproxen, or others) O have 3 or more a coholic drinks every day while using
this product O take more or for a onger time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart a tack, heart fai ure, and stroke. These can be fatal. The risk is higher if you use more than directed or for onger than directed.
BIONPHARMA
Labeling Format Information:
Fonts: Helvetica Condensed Bold, Helvetica Condensed, Helvetica Condensed Bold Oblique
Drug Facts: 8pt Header: 7pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): 7pt
Horizontal Scale: 100% Average Kerning: 0%
Leading: 7.2pt Bullets: 5pt Barlines: .6pt Hairlines: .2pt
Reference ID: 4601010
40 CAPSULES
Actual Size
SSAID)))
Do not use if printed safety seal under cap istorn or m
issing.
r ecu
deRr
eveF
/rev
eileR
niaP
mui d
oSne
xor p
aNg
m02
2,se
l usp
aC) D
I ASN
(
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 m
g (NSAID)
Strength to last 12 hours
NDC 69452-179-15
Lot No :
Exp. Date:
A SAID) 40 C AP SU LE S
Actual Size
Manufactured for:
BIONPHARMA 600 A exander Road, Princeton, NJ 08540
Do not use O if you have ever had an allergic reaction to any other pain re iever/fever reducer O right before or after heart surgery Ask a doctor before use f O stomach bleeding warning applies to you O you have a history of stomach problems, such as heartburn O you have high blood pressure, heart disease, liver cirrhosis,
kidney disease, asthma, or had a stroke O you are taking a diuretic O you have prob ems or serious side effects from taking pain
relievers or fever reducers
Drug Facts (continued)
Ask a doctor or pharmacist before use f you are O under a doctor's care for any serious condition O taking aspirin for heart a tack or stroke, because naproxen
may decrease this benefit of aspirin O taking any other drug When using this product O take with food or milk if stomach upset occurs Stop use and ask a doctor if O you experience any of the fol owing signs of stomach
bleeding: O feel faint O vomit blood O have b oody or black stoo s O have stomach pain that does not get better O you have symptoms of heart problems or stroke: O chest pain O troub e breathing O weakness in one part or side of body O slurred speech O eg swe ling O pain gets worse or lasts more than 0 days O fever gets worse or lasts more than 3 days O redness or swe ling is present in the painful area O any new symptoms appear O you have di ficu ty swa lowing O it feels like the capsule is stuck in your throat
f pregnant or breast feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during de ivery. Keep out of reach of children. In case of overdose, get medical he p or contact a Poison Control Center right away.
Directions O do not take more than directed O he sma lest effective dose should be used O drink a full glass of water with each dose O if taken with food, this product may take onger to work
Drug Facts (cont nued)
Other information O each capsule contains: sodium 20 mg O store at 20-25°C (68-77°F) avoid high humidity and
excessive heat above 40°C (104°F). O Protect from ight. O read all directions and warnings before use. Keep carton.
Inactive ingredients FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethy ene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Questions or comments? 1 888 235 2466 (Mon - Fri 9AM - 5PM EST)
O take 1 capsule every 8 to 2 hours whi e symptoms last
O for the first dose you may take 2 capsules within the first hour
O do not exceed 2 capsules in any 8- to 12-hour period
O do not exceed 3 capsu es in a 24-hour period
adults and chi dren 2 years and o der:
children under 2 years: O ask a doctor
R0220 L0000000
Drug Facts Active ingredient (in each capsule) Purposes Naproxen sodium 220 mg (naproxen 200 mg (NSAID)*.. ... .. .. Pain re iever/fever reducer *nonsteroidal anti-inflammatory drug
Uses O temporarily re ieves minor aches and pains due to: O minor pain of arthritis O muscular aches O backache O menstrual cramps O headache O toothache O the common co d
O temporarily reduces fever
Warnings Allergy alert: Naproxen sodium may cause a severe a lergic reaction, especially in people allergic to aspirin. Symptoms may include: O hives O facial swe ling O asthma (wheezing) O shock O skin reddening O rash O blisters If an al ergic reaction occurs, stop use and seek medical he p right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or older O have had stomach ulcers or b eeding prob ems O take a b ood thinning (anticoagulant) or steroid drug O take other drugs containing prescription or nonprescription
NSAIDs (aspirin, ibuprofen, naproxen, or others) O have 3 or more a coholic drinks every day while using
this product O take more or for a onger time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart a tack, heart fai ure, and stroke. These can be fatal. The risk is higher if you use more than directed or for onger than directed.
BIONPHARMA
Labeling Format Information:
Fonts: Helvetica Condensed Bold, Helvetica Condensed, Helvetica Condensed Bold Oblique
Drug Facts: 8pt Header: 7pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): 7pt
Horizontal Scale: 100% Average Kerning: 0%
Leading: 7.2pt Bullets: 5pt Barlines: .6pt Hairlines: .2pt
Reference ID: 4601010
40 CAPSULES
Actual Size
SSAID)))
Do not use if printed safety seal under cap istorn or m
issing.
r ecu
deRr
eveF
/rev
eileR
niaP
mui d
oSne
xor p
aNg
m02
2,se
l usp
aC) D
I ASN
(
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 m
g (NSAID)
Strength to last 12 hours
NDC 69452-179-15
Lot No :
Exp. Date:
A SAID) 40 C AP SU LE S
Actual Size
Manufactured for:
BIONPHARMA 600 A exander Road, Princeton, NJ 08540
Do not use O if you have ever had an allergic reaction to any other pain re iever/fever reducer O right before or after heart surgery Ask a doctor before use f O stomach bleeding warning applies to you O you have a history of stomach problems, such as heartburn O you have high blood pressure, heart disease, liver cirrhosis,
kidney disease, asthma, or had a stroke O you are taking a diuretic O you have prob ems or serious side effects from taking pain
relievers or fever reducers
Drug Facts (continued)
Ask a doctor or pharmacist before use f you are O under a doctor's care for any serious condition O taking aspirin for heart a tack or stroke, because naproxen
may decrease this benefit of aspirin O taking any other drug When using this product O take with food or milk if stomach upset occurs Stop use and ask a doctor if O you experience any of the fol owing signs of stomach
bleeding: O feel faint O vomit blood O have b oody or black stoo s O have stomach pain that does not get better O you have symptoms of heart problems or stroke: O chest pain O troub e breathing O weakness in one part or side of body O slurred speech O eg swe ling O pain gets worse or lasts more than 0 days O fever gets worse or lasts more than 3 days O redness or swe ling is present in the painful area O any new symptoms appear O you have di ficu ty swa lowing O it feels like the capsule is stuck in your throat
f pregnant or breast feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during de ivery. Keep out of reach of children. In case of overdose, get medical he p or contact a Poison Control Center right away.
Directions O do not take more than directed O he sma lest effective dose should be used O drink a full glass of water with each dose O if taken with food, this product may take onger to work
Drug Facts (cont nued)
Other information O each capsule contains: sodium 20 mg O store at 20-25°C (68-77°F) avoid high humidity and
excessive heat above 40°C (104°F). O Protect from ight. O read all directions and warnings before use. Keep carton.
Inactive ingredients FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethy ene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Questions or comments? 1 888 235 2466 (Mon - Fri 9AM - 5PM EST)
O take 1 capsule every 8 to 2 hours whi e symptoms last
O for the first dose you may take 2 capsules within the first hour
O do not exceed 2 capsules in any 8- to 12-hour period
O do not exceed 3 capsu es in a 24-hour period
adults and chi dren 2 years and o der:
children under 2 years: O ask a doctor
R0220 L0000000
***This product s not manufactured or distributed by the owners of ALEVE® Liqu d Gels.
Compare to the active ingredient
of ALEVE ® Liquid Gels***
Drug Facts Active ingredient (in each capsule) Purposes Naproxen sodium 220 mg (naproxen 200 mg (NSAID)*.. ... .. .. Pain re iever/fever reducer *nonsteroidal anti-inflammatory drug
Uses O temporarily re ieves minor aches and pains due to: O minor pain of arthritis O muscular aches O backache O menstrual cramps O headache O toothache O the common co d
O temporarily reduces fever
Warnings Allergy alert: Naproxen sodium may cause a severe a lergic reaction, especially in people allergic to aspirin. Symptoms may include: O hives O facial swe ling O asthma (wheezing) O shock O skin reddening O rash O blisters If an al ergic reaction occurs, stop use and seek medical he p right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or older O have had stomach ulcers or b eeding prob ems O take a b ood thinning (anticoagulant) or steroid drug O take other drugs containing prescription or nonprescription
NSAIDs (aspirin, ibuprofen, naproxen, or others) O have 3 or more a coholic drinks every day while using
this product O take more or for a onger time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart a tack, heart fai ure, and stroke. These can be fatal. The risk is higher if you use more than directed or for onger than directed.
BIONPHARMA
Labeling Format Information:
Fonts: Helvetica Condensed Bold, Helvetica Condensed, Helvetica Condensed Bold Oblique
Drug Facts: 8pt Header: 7pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): 7pt
Horizontal Scale: 100% Average Kerning: 0%
Leading: 7.2pt Bullets: 5pt Barlines: .6pt Hairlines: .2pt
Reference ID: 4601010
50 CAPSULES
Actual Size
SSAID)))
Do not use if printed safety seal under cap istorn or m
issing.
r ecu
deRr
eveF
/rev
eileR
niaP
mui d
oSne
xor p
aNg
m02
2,se
l usp
aC) D
I ASN
(
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 m
g (NSAID)
Strength to last 12 hours
NDC 69452-179-16
Lot No :
Exp. Date:
A SAID) 50 C AP SU LE S
Actual Size
Manufactured for:
BIONPHARMA 600 A exander Road, Princeton, NJ 08540
Do not use O if you have ever had an allergic reaction to any other pain re iever/fever reducer O right before or after heart surgery Ask a doctor before use f O stomach bleeding warning applies to you O you have a history of stomach problems, such as heartburn O you have high blood pressure, heart disease, liver cirrhosis,
kidney disease, asthma, or had a stroke O you are taking a diuretic O you have prob ems or serious side effects from taking pain
relievers or fever reducers
Drug Facts (continued)
Ask a doctor or pharmacist before use f you are O under a doctor's care for any serious condition O taking aspirin for heart a tack or stroke, because naproxen
may decrease this benefit of aspirin O taking any other drug When using this product O take with food or milk if stomach upset occurs Stop use and ask a doctor if O you experience any of the fol owing signs of stomach
bleeding: O feel faint O vomit blood O have b oody or black stoo s O have stomach pain that does not get better O you have symptoms of heart problems or stroke: O chest pain O troub e breathing O weakness in one part or side of body O slurred speech O eg swe ling O pain gets worse or lasts more than 0 days O fever gets worse or lasts more than 3 days O redness or swe ling is present in the painful area O any new symptoms appear O you have di ficu ty swa lowing O it feels like the capsule is stuck in your throat
f pregnant or breast feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during de ivery. Keep out of reach of children. In case of overdose, get medical he p or contact a Poison Control Center right away.
Directions O do not take more than directed O he sma lest effective dose should be used O drink a full glass of water with each dose O if taken with food, this product may take onger to work
Drug Facts (cont nued)
Other information O each capsule contains: sodium 20 mg O store at 20-25°C (68-77°F) avoid high humidity and
excessive heat above 40°C (104°F). O Protect from ight. O read all directions and warnings before use. Keep carton.
Inactive ingredients FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethy ene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Questions or comments? 1 888 235 2466 (Mon - Fri 9AM - 5PM EST)
O take 1 capsule every 8 to 2 hours whi e symptoms last
O for the first dose you may take 2 capsules within the first hour
O do not exceed 2 capsules in any 8- to 12-hour period
O do not exceed 3 capsu es in a 24-hour period
adults and chi dren 2 years and o der:
children under 2 years: O ask a doctor
R0220 L0000000
Drug Facts Active ingredient (in each capsule) Purposes Naproxen sodium 220 mg (naproxen 200 mg (NSAID)*.. ... .. .. Pain re iever/fever reducer *nonsteroidal anti-inflammatory drug
Uses O temporarily re ieves minor aches and pains due to: O minor pain of arthritis O muscular aches O backache O menstrual cramps O headache O toothache O the common co d
O temporarily reduces fever
Warnings Allergy alert: Naproxen sodium may cause a severe a lergic reaction, especially in people allergic to aspirin. Symptoms may include: O hives O facial swe ling O asthma (wheezing) O shock O skin reddening O rash O blisters If an al ergic reaction occurs, stop use and seek medical he p right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or older O have had stomach ulcers or b eeding prob ems O take a b ood thinning (anticoagulant) or steroid drug O take other drugs containing prescription or nonprescription
NSAIDs (aspirin, ibuprofen, naproxen, or others) O have 3 or more a coholic drinks every day while using
this product O take more or for a onger time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart a tack, heart fai ure, and stroke. These can be fatal. The risk is higher if you use more than directed or for onger than directed.
BIONPHARMA
Labeling Format Information:
Fonts: Helvetica Condensed Bold, Helvetica Condensed, Helvetica Condensed Bold Oblique
Drug Facts: 8pt Header: 7pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): 7pt
Horizontal Scale: 100% Average Kerning: 0%
Leading: 7.2pt Bullets: 5pt Barlines: .6pt Hairlines: .2pt
Reference ID: 4601010
50 CAPSULES
Actual Size
SSAID)))
Do not use if printed safety seal under cap istorn or m
issing.
r ecu
deRr
eveF
/rev
eileR
niaP
mui d
oSne
xor p
aNg
m02
2,se
l usp
aC) D
I ASN
(
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 m
g (NSAID)
Strength to last 12 hours
NDC 69452-179-16
Lot No :
Exp. Date:
A SAID) 50 C AP SU LE S
Actual Size
Manufactured for:
BIONPHARMA 600 A exander Road, Princeton, NJ 08540
Do not use O if you have ever had an allergic reaction to any other pain re iever/fever reducer O right before or after heart surgery Ask a doctor before use f O stomach bleeding warning applies to you O you have a history of stomach problems, such as heartburn O you have high blood pressure, heart disease, liver cirrhosis,
kidney disease, asthma, or had a stroke O you are taking a diuretic O you have prob ems or serious side effects from taking pain
relievers or fever reducers
Drug Facts (continued)
Ask a doctor or pharmacist before use f you are O under a doctor's care for any serious condition O taking aspirin for heart a tack or stroke, because naproxen
may decrease this benefit of aspirin O taking any other drug When using this product O take with food or milk if stomach upset occurs Stop use and ask a doctor if O you experience any of the fol owing signs of stomach
bleeding: O feel faint O vomit blood O have b oody or black stoo s O have stomach pain that does not get better O you have symptoms of heart problems or stroke: O chest pain O troub e breathing O weakness in one part or side of body O slurred speech O eg swe ling O pain gets worse or lasts more than 0 days O fever gets worse or lasts more than 3 days O redness or swe ling is present in the painful area O any new symptoms appear O you have di ficu ty swa lowing O it feels like the capsule is stuck in your throat
f pregnant or breast feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during de ivery. Keep out of reach of children. In case of overdose, get medical he p or contact a Poison Control Center right away.
Directions O do not take more than directed O he sma lest effective dose should be used O drink a full glass of water with each dose O if taken with food, this product may take onger to work
Drug Facts (cont nued)
Other information O each capsule contains: sodium 20 mg O store at 20-25°C (68-77°F) avoid high humidity and
excessive heat above 40°C (104°F). O Protect from ight. O read all directions and warnings before use. Keep carton.
Inactive ingredients FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethy ene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Questions or comments? 1 888 235 2466 (Mon - Fri 9AM - 5PM EST)
O take 1 capsule every 8 to 2 hours whi e symptoms last
O for the first dose you may take 2 capsules within the first hour
O do not exceed 2 capsules in any 8- to 12-hour period
O do not exceed 3 capsu es in a 24-hour period
adults and chi dren 2 years and o der:
children under 2 years: O ask a doctor
R0220 L0000000
***This product s not manufactured or distributed by the owners of ALEVE® Liqu d Gels.
Compare to the active ingredient
of ALEVE ® Liquid Gels***
Drug Facts Active ingredient (in each capsule) Purposes Naproxen sodium 220 mg (naproxen 200 mg (NSAID)*.. ... .. .. Pain re iever/fever reducer *nonsteroidal anti-inflammatory drug
Uses O temporarily re ieves minor aches and pains due to: O minor pain of arthritis O muscular aches O backache O menstrual cramps O headache O toothache O the common co d
O temporarily reduces fever
Warnings Allergy alert: Naproxen sodium may cause a severe a lergic reaction, especially in people allergic to aspirin. Symptoms may include: O hives O facial swe ling O asthma (wheezing) O shock O skin reddening O rash O blisters If an al ergic reaction occurs, stop use and seek medical he p right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or older O have had stomach ulcers or b eeding prob ems O take a b ood thinning (anticoagulant) or steroid drug O take other drugs containing prescription or nonprescription
NSAIDs (aspirin, ibuprofen, naproxen, or others) O have 3 or more a coholic drinks every day while using
this product O take more or for a onger time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart a tack, heart fai ure, and stroke. These can be fatal. The risk is higher if you use more than directed or for onger than directed.
BIONPHARMA
Labeling Format Information:
Fonts: Helvetica Condensed Bold, Helvetica Condensed, Helvetica Condensed Bold Oblique
Drug Facts: 8pt Header: 7pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): 7pt
Horizontal Scale: 100% Average Kerning: 0%
Leading: 7.2pt Bullets: 5pt Barlines: .6pt Hairlines: .2pt
Reference ID: 4601010
)))
80 CAPSULES
Actual Size
Drug
Fac
tsAc
tive
ingr
edie
nt (i
n ea
ch ca
psul
e)
Purp
oses
Na
prox
en so
dium
220
mg
(nap
roxe
n 20
0 m
g) (N
SAID
)*....
.... ..
.. ... .
... ....
.... ..
.Pain
relie
ver f
ever
redu
cer
*non
stero
idal a
nti-i
nflam
mato
ry d
rug
Uses
O te
mpo
raril
y reli
eves
min
or ac
hes a
nd p
ains d
ue to
:O
min
or p
ain o
f arth
ritis O
mus
cular
ache
s O
bac
kach
e O
men
stru
al cr
amps
O
hea
dach
e O
toot
hach
e O
the c
omm
on co
ldO
tem
pora
rily r
educ
es fe
ver
War
ning
sAl
lerg
y ale
rt: N
apro
xen
sodi
um m
ay ca
use a
seve
re al
lergi
c rea
ctio
n,es
pecia
lly in
peo
ple a
llerg
ic to
aspi
rin. S
ympt
oms m
ay in
clude
:O
hive
s O
facia
l swe
lling O
asth
ma (
whee
zing)
O s
hock
O
skin
redd
enin
g O
rash
O
blis
ters
If an
aller
gic r
eact
ion
occu
rs, s
top
use a
nd se
ek m
edica
l help
righ
t awa
y.St
omac
h bl
eedi
ng w
arni
ng: T
his p
rodu
ct co
ntain
s an
NSAI
D, w
hich
may
caus
e sev
ere s
tom
ach
blee
ding
. The
chan
ce is
hig
her i
f you
:O
are a
ge 6
0 or
old
erO
hav
e had
stom
ach
ulce
rs o
r blee
ding
pro
blem
sO
take
a bl
ood
thin
ning
(ant
icoag
ulan
t) or
ster
oid
drug
O ta
ke o
ther
dru
gs co
ntain
ing
pres
crip
tion
or n
onpr
escr
iptio
n NS
AIDs
(asp
irin,
ibup
rofe
n, n
apro
xen,
or o
ther
s)O
hav
e 3 o
r mor
e alco
holic
drin
ks ev
ery d
ay w
hile
usin
g th
is pr
oduc
tO
take
mor
e or f
or a
long
er ti
me t
han
dire
cted
Hear
t atta
ck a
nd st
roke
war
ning
: NSA
IDs,
exce
pt as
pirin
, inc
reas
e the
risk
of h
eart
atta
ck, h
eart
failu
re, a
nd st
roke
. The
se ca
n be
fata
l. Th
e risk
ishi
gher
if yo
u us
e mor
e tha
n di
rect
ed o
r for
long
er th
an d
irect
ed.
Do n
ot u
seO
if yo
u ha
ve ev
er h
ad an
a ler
gic r
eact
ion
to an
y oth
er p
ain re
lieve
r fev
er
redu
cer
O ri
ght b
efor
e or a
fter h
eart
surg
ery
Ask a
doc
tor b
efor
e us
e f
O st
omac
h bl
eedi
ng w
arni
ng ap
plies
to yo
uO
you
have
a hi
stor
y of s
tom
ach
prob
lems,
such
as h
eartb
urn
O yo
u ha
ve h
igh
bloo
d pr
essu
re, h
eart
dise
ase,
liver
cirrh
osis,
kidn
eydi
seas
e, as
thm
a, or
had
a st
roke
O yo
u ar
e tak
ing
a diu
retic
O yo
u ha
ve p
robl
ems o
r ser
ious
side
effe
cts f
rom
takin
g pa
in re
lieve
rs o
rfe
ver r
educ
ers
Do not use if printed safety seal under cap istorn or missing.
recudeRreveF/reveileRniaP
muidoSnexorpaNgm022,seluspaC
)DIASN(
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg (NSAID)
Strength to last 12 hours
NDC 69452 179 78
80 CAPSULES
Actual Size
Man
ufac
ture
d fo
r:BI
ON
PHAR
MA
600
Alex
ande
r Roa
d,Pr
ince
ton,
NJ
0854
0
Lot N
o.:
Exp.
Date
:
R022
0L0
0000
00
Drug
Fac
ts (c
ontin
ued)
Stop
use
and
ask
a d
octo
r if
O yo
u ex
perie
nce a
ny o
f the
follo
wing
sign
s of s
tom
ach
blee
ding
:O
feel
fain
t O
vom
it bl
ood O
hav
e blo
ody o
r blac
k sto
ols
O h
ave s
tom
ach
pain
that
doe
s not
get
bet
ter
O yo
u ha
ve sy
mpt
oms o
f hea
rt pr
oblem
s or s
troke
:O
ches
t pain
O
trou
ble b
reat
hing
O w
eakn
ess i
n on
e par
t or s
ide o
f bod
yO
slur
red
spee
ch O
leg
swell
ing
O p
ain g
ets w
orse
or l
asts
mor
e tha
n 10
day
sO
feve
r get
s wor
se o
r las
ts m
ore t
han
3 da
ysO
redn
ess o
r swe
lling
is pr
esen
t in
the p
ainfu
l are
aO
any n
ew sy
mpt
oms a
ppea
rO
you
have
diff
iculty
swall
owing
O it
feels
like t
he ca
psul
e is s
tuck
in yo
ur th
roat
If pr
egna
nt o
r bre
ast-f
eedi
ng, a
sk a
hea t
h pr
ofes
siona
l bef
ore u
se. I
t is
espe
cially
impo
rtant
not
to u
se n
apro
xen
sodi
um d
urin
g th
e las
t 3 m
onth
sof
pre
gnan
cy u
nles
s def
inite
ly di
rect
ed to
do
so b
y a d
octo
r bec
ause
it m
ayca
use p
robl
ems i
n th
e unb
orn
child
or c
ompl
icatio
ns d
urin
g de
liver
y.Ke
ep o
ut o
f rea
ch o
f chi
ldre
n. In
case
of o
verd
ose,
get m
edica
l help
or
cont
act a
Poi
son
Cont
rol C
ente
r rig
ht aw
ay.
Dire
ctio
nsO
do
not t
ake
mor
e th
an d
irect
edO
the
smal
lest
effe
c iv
e do
se sh
ould
be
used
O
drin
k a fu
ll glas
s of w
ater
with
each
dos
eO
if ta
ken
with
food
, thi
s pro
duct
may
take
long
er to
wor
kO
take
1 ca
psul
e eve
ry 8
to
2 ho
urs w
hile
sym
ptom
s las
t O
for t
he fi
rst d
ose y
ou m
ay ta
ke 2
caps
ules
with
in th
efir
st h
our
O d
o no
t exc
eed
2 ca
psul
es in
any 8
- to
12-h
our p
erio
dO
do
not e
xcee
d 3
caps
ules
in a
24-h
our p
erio
d
adul
ts an
dch
ildre
n12
year
s and
olde
r:
ch ld
ren
unde
r 12
year
s: O
ask
a do
ctor
Ask a
doc
tor o
r pha
rmac
ist b
efor
e us
e if
you
are
O u
nder
a do
ctor
's ca
re fo
r any
serio
us co
nditi
onO
takin
g as
pirin
for h
eart
atta
ck o
r stro
ke, b
ecau
se n
apro
xen
may
decr
ease
this
bene
fit o
f asp
irin
O ta
king
any o
ther
dru
gW
hen
usin
g th
is p
rodu
ctO
take
with
food
or m
ilk if
stom
ach
upse
t occ
urs
Drug
Fac
ts (c
ontin
ued)
Othe
r inf
orm
atio
nO
eac
h ca
psul
e co
ntai
ns: s
odiu
m 2
0 m
gO
stor
e at 2
0-25
°C (6
8-77
°F) a
void
hig
h hu
mid
ity an
d ex
cess
ive h
eat a
bove
40°C
(104
°F).
O P
rotec
t from
light.
O re
ad al
l dire
ctio
ns an
d wa
rnin
gs b
efor
e use
. Kee
p ca
rton.
Inac
tive
ingr
edie
nts
FD&C
blu
e #1,
gela
tin, g
lycer
in, l
actic
acid
, man
nito
l, ph
arm
aceu
tical
ink,
polye
thyle
ne g
lycol
, pov
idon
e, pr
opyle
ne g
lycol
, pur
ified
wat
er, s
orbi
tan,
sorb
itol
Ques
tions
or c
omm
ents
? 1-
888-
235-
2466
(Mon
- Fri
9AM
- 5P
M ES
T)
BIO
NPH
ARM
AL
ab
eli
ng
Fo
rma
t In
form
ati
on
:
Fo
nts
: Hel
vetic
a Co
nden
sed
Bold
, Hel
vetic
a Co
nden
sed,
H
elve
tica
Cond
ense
d Bo
ld O
bliq
ue
Dru
g F
ac
ts:
8pt
He
ad
er:
7pt
S
ub
he
ad
er:
6p
t B
od
y T
ex
t:
6pt
Dru
g F
ac
ts (c
ontin
ued)
: 7p
t
Hor
izon
tal S
cale
: 100
%
Aver
age
Kern
ing:
0%
Le
ad
ing
: 7.
2pt
Bu
lle
ts:
5pt
B
arl
ine
s:
.6pt
H
air
lin
es:
.2
pt
Reference ID: 4601010
)))
80 CAPSULES
Actual Size
Drug
Fac
tsAc
tive
ingr
edie
nt (i
n ea
ch ca
psul
e)
Purp
oses
Na
prox
en so
dium
220
mg
(nap
roxe
n 20
0 m
g) (N
SAID
)*....
.... ..
.. ... .
... ....
.... ..
.Pain
relie
ver f
ever
redu
cer
*non
stero
idal a
nti-i
nflam
mato
ry d
rug
Uses
O te
mpo
raril
y reli
eves
min
or ac
hes a
nd p
ains d
ue to
:O
min
or p
ain o
f arth
ritis O
mus
cular
ache
s O
bac
kach
e O
men
stru
al cr
amps
O
hea
dach
e O
toot
hach
e O
the c
omm
on co
ldO
tem
pora
rily r
educ
es fe
ver
War
ning
sAl
lerg
y ale
rt: N
apro
xen
sodi
um m
ay ca
use a
seve
re al
lergi
c rea
ctio
n,es
pecia
lly in
peo
ple a
llerg
ic to
aspi
rin. S
ympt
oms m
ay in
clude
:O
hive
s O
facia
l swe
lling O
asth
ma (
whee
zing)
O s
hock
O
skin
redd
enin
g O
rash
O
blis
ters
If an
aller
gic r
eact
ion
occu
rs, s
top
use a
nd se
ek m
edica
l help
righ
t awa
y.St
omac
h bl
eedi
ng w
arni
ng: T
his p
rodu
ct co
ntain
s an
NSAI
D, w
hich
may
caus
e sev
ere s
tom
ach
blee
ding
. The
chan
ce is
hig
her i
f you
:O
are a
ge 6
0 or
old
erO
hav
e had
stom
ach
ulce
rs o
r blee
ding
pro
blem
sO
take
a bl
ood
thin
ning
(ant
icoag
ulan
t) or
ster
oid
drug
O ta
ke o
ther
dru
gs co
ntain
ing
pres
crip
tion
or n
onpr
escr
iptio
n NS
AIDs
(asp
irin,
ibup
rofe
n, n
apro
xen,
or o
ther
s)O
hav
e 3 o
r mor
e alco
holic
drin
ks ev
ery d
ay w
hile
usin
g th
is pr
oduc
tO
take
mor
e or f
or a
long
er ti
me t
han
dire
cted
Hear
t atta
ck a
nd st
roke
war
ning
: NSA
IDs,
exce
pt as
pirin
, inc
reas
e the
risk
of h
eart
atta
ck, h
eart
failu
re, a
nd st
roke
. The
se ca
n be
fata
l. Th
e risk
ishi
gher
if yo
u us
e mor
e tha
n di
rect
ed o
r for
long
er th
an d
irect
ed.
Do n
ot u
seO
if yo
u ha
ve ev
er h
ad an
a ler
gic r
eact
ion
to an
y oth
er p
ain re
lieve
r fev
er
redu
cer
O ri
ght b
efor
e or a
fter h
eart
surg
ery
Ask a
doc
tor b
efor
e us
e f
O st
omac
h bl
eedi
ng w
arni
ng ap
plies
to yo
uO
you
have
a hi
stor
y of s
tom
ach
prob
lems,
such
as h
eartb
urn
O yo
u ha
ve h
igh
bloo
d pr
essu
re, h
eart
dise
ase,
liver
cirrh
osis,
kidn
eydi
seas
e, as
thm
a, or
had
a st
roke
O yo
u ar
e tak
ing
a diu
retic
O yo
u ha
ve p
robl
ems o
r ser
ious
side
effe
cts f
rom
takin
g pa
in re
lieve
rs o
rfe
ver r
educ
ers
Do not use if printed safety seal under cap istorn or missing.
recudeRreveF/reveileRniaP
muidoSnexorpaNgm022,seluspaC
)DIASN(
Compare to the active ingredient of ALEVE ® Liquid Gels***
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg (NSAID)
Strength to last 12 hours
NDC 69452 179 78
80 CAPSULES
Actual Size
Man
ufac
ture
d fo
r:BI
ON
PHAR
MA
600
Alex
ande
r Roa
d,Pr
ince
ton,
NJ
0854
0
Lot N
o.:
Exp.
Date
:
R022
0L0
0000
00
Drug
Fac
ts (c
ontin
ued)
Stop
use
and
ask
a d
octo
r if
O yo
u ex
perie
nce a
ny o
f the
follo
wing
sign
s of s
tom
ach
blee
ding
:O
feel
fain
t O
vom
it bl
ood O
hav
e blo
ody o
r blac
k sto
ols
O h
ave s
tom
ach
pain
that
doe
s not
get
bet
ter
O yo
u ha
ve sy
mpt
oms o
f hea
rt pr
oblem
s or s
troke
:O
ches
t pain
O
trou
ble b
reat
hing
O w
eakn
ess i
n on
e par
t or s
ide o
f bod
yO
slur
red
spee
ch O
leg
swell
ing
O p
ain g
ets w
orse
or l
asts
mor
e tha
n 10
day
sO
feve
r get
s wor
se o
r las
ts m
ore t
han
3 da
ysO
redn
ess o
r swe
lling
is pr
esen
t in
the p
ainfu
l are
aO
any n
ew sy
mpt
oms a
ppea
rO
you
have
diff
iculty
swall
owing
O it
feels
like t
he ca
psul
e is s
tuck
in yo
ur th
roat
If pr
egna
nt o
r bre
ast-f
eedi
ng, a
sk a
hea t
h pr
ofes
siona
l bef
ore u
se. I
t is
espe
cially
impo
rtant
not
to u
se n
apro
xen
sodi
um d
urin
g th
e las
t 3 m
onth
sof
pre
gnan
cy u
nles
s def
inite
ly di
rect
ed to
do
so b
y a d
octo
r bec
ause
it m
ayca
use p
robl
ems i
n th
e unb
orn
child
or c
ompl
icatio
ns d
urin
g de
liver
y.Ke
ep o
ut o
f rea
ch o
f chi
ldre
n. In
case
of o
verd
ose,
get m
edica
l help
or
cont
act a
Poi
son
Cont
rol C
ente
r rig
ht aw
ay.
Dire
ctio
nsO
do
not t
ake
mor
e th
an d
irect
edO
the
smal
lest
effe
c iv
e do
se sh
ould
be
used
O
drin
k a fu
ll glas
s of w
ater
with
each
dos
eO
if ta
ken
with
food
, thi
s pro
duct
may
take
long
er to
wor
kO
take
1 ca
psul
e eve
ry 8
to
2 ho
urs w
hile
sym
ptom
s las
t O
for t
he fi
rst d
ose y
ou m
ay ta
ke 2
caps
ules
with
in th
efir
st h
our
O d
o no
t exc
eed
2 ca
psul
es in
any 8
- to
12-h
our p
erio
dO
do
not e
xcee
d 3
caps
ules
in a
24-h
our p
erio
d
adul
ts an
dch
ildre
n12
year
s and
olde
r:
ch ld
ren
unde
r 12
year
s: O
ask
a do
ctor
Ask a
doc
tor o
r pha
rmac
ist b
efor
e us
e if
you
are
O u
nder
a do
ctor
's ca
re fo
r any
serio
us co
nditi
onO
takin
g as
pirin
for h
eart
atta
ck o
r stro
ke, b
ecau
se n
apro
xen
may
decr
ease
this
bene
fit o
f asp
irin
O ta
king
any o
ther
dru
g
Whe
n us
ing
this
pro
duct
O ta
ke w
ith fo
od o
r milk
if st
omac
h up
set o
ccur
s
***T
his
prod
uct i
s no
t man
ufac
ture
d or
dist
ribut
ed b
y th
e ow
ners
of A
LEVE
® L
iqui
d Ge
ls.
Drug
Fac
ts (c
ontin
ued)
Othe
r inf
orm
atio
nO
eac
h ca
psul
e co
ntai
ns: s
odiu
m 2
0 m
gO
stor
e at 2
0-25
°C (6
8-77
°F) a
void
hig
h hu
mid
ity an
d ex
cess
ive h
eat a
bove
40°C
(104
°F).
O P
rotec
t from
light.
O re
ad al
l dire
ctio
ns an
d wa
rnin
gs b
efor
e use
. Kee
p ca
rton.
Inac
tive
ingr
edie
nts
FD&C
blu
e #1,
gela
tin, g
lycer
in, l
actic
acid
, man
nito
l, ph
arm
aceu
tical
ink,
polye
thyle
ne g
lycol
, pov
idon
e, pr
opyle
ne g
lycol
, pur
ified
wat
er, s
orbi
tan,
sorb
itol
Ques
tions
or c
omm
ents
? 1-
888-
235-
2466
(Mon
- Fri
9AM
- 5P
M ES
T)
BIO
NPH
ARM
AL
ab
eli
ng
Fo
rma
t In
form
ati
on
:
Fo
nts
: Hel
vetic
a Co
nden
sed
Bold
, Hel
vetic
a Co
nden
sed,
H
elve
tica
Cond
ense
d Bo
ld O
bliq
ue
Dru
g F
ac
ts:
8pt
He
ad
er:
7pt
S
ub
he
ad
er:
6p
t B
od
y T
ex
t:
6pt
Dru
g F
ac
ts (c
ontin
ued)
: 7p
t
Hor
izon
tal S
cale
: 100
%
Aver
age
Kern
ing:
0%
Le
ad
ing
: 7.
2pt
Bu
lle
ts:
5pt
B
arl
ine
s:
.6pt
H
air
lin
es:
.2
pt
Reference ID: 4601010
BIO
NPH
ARM
AL
ab
eli
ng
Fo
rma
t In
form
ati
on
:
Fo
nts
: Hel
vetic
a Co
nden
sed
Bold
, Hel
vetic
a Co
nden
sed,
H
elve
tica
Cond
ense
d Bo
ld O
bliq
ue
Dru
g F
ac
ts:
8pt
He
ad
er:
7pt
S
ub
he
ad
er:
6p
t B
od
y T
ex
t:
6pt
Dru
g F
ac
ts (c
ontin
ued)
: 7p
t
Hor
izon
tal S
cale
: 100
%
Aver
age
Kern
ing:
0%
Le
ad
ing
: 7.
2pt
Bu
lle
ts:
5pt
B
arl
ine
s:
.6pt
H
air
lin
es:
.2
pt
THIS
PACK
AGE F
OR HO
USEH
OLDS
WITH
OUT Y
OUNG
CHILD
REN
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
ARTHRITIS CAPEASY OPEN
ARTH
RITI
S CA
PEA
SYOP
EN
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg (NSAID)
Strength to last 12 hours
80 CAPSULES
NDC 69452-179-78
Napr
oxen
Sod
ium
Caps
ules
, 220
mg
(NSA
ID)
Pain
Rel
ieve
r/Fev
er R
educ
er
80 C
APSU
LES
Stre
ngth
to la
st 1
2 ho
urs
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg(NSAID)
Man
ufac
ture
d fo
r:Bi
onph
arm
a In
c.60
0 Al
exan
der R
oad,
Prin
ceto
n, N
J 08
540
Drug
Fac
tsAc
tive
ingr
edie
nt (i
n ea
ch ca
psul
e)
Purp
oses
Na
prox
en so
dium
220
mg
(nap
roxe
n 20
0 m
g) (N
SAID
)*.. .
... ....
..... .
... ....
.... ..
... ....
.... ..
... Pa
in re
lieve
r fev
er re
duce
r *n
onste
roida
l ant
i-inf
lamm
atory
dru
g
Uses
O te
mpo
raril
y reli
eves
min
or ac
hes a
nd p
ains d
ue to
:O
min
or p
ain o
f arth
ritis O
mus
cular
ache
s O
bac
kach
e O
men
stru
al cr
amps
O
hea
dach
e O
toot
hach
e O
the c
omm
on co
ldO
tem
pora
rily r
educ
es fe
ver
War
ning
sAl
lerg
y ale
rt: N
apro
xen
sodi
um m
ay ca
use a
seve
re a
lergi
c rea
ctio
n, es
pecia
lly in
pe
ople
aller
gic t
o as
pirin
. Sym
ptom
s may
inclu
de:
O h
ives O
facia
l swe
lling O
asth
ma (
whee
zing)
O s
hock
O
skin
redd
enin
g O
rash
O
blis
ters
If an
aller
gic r
eact
ion
occu
rs, s
top
use a
nd se
ek m
edica
l help
righ
t awa
y.St
omac
h bl
eedi
ng w
arni
ng: T
his p
rodu
ct co
ntain
s an
NSAI
D, w
hich
may
caus
ese
vere
stom
ach
blee
ding
. The
chan
ce is
hig
her i
f you
:O
are a
ge 6
0 or
old
erO
hav
e had
stom
ach
ulce
rs o
r blee
ding
pro
blem
sO
take
a bl
ood
thin
ning
(ant
icoag
ulan
t) or
ster
oid
drug
O ta
ke o
ther
dru
gs co
ntain
ing
pres
crip
tion
or n
onpr
escr
iptio
n NS
AIDs
(asp
irin,
ibup
rofe
n, n
apro
xen,
or o
ther
s)O
hav
e 3 o
r mor
e alco
holic
drin
ks ev
ery d
ay w
hile
usin
g th
is pr
oduc
tO
take
mor
e or f
or a
long
er ti
me t
han
dire
cted
Hear
t atta
ck a
nd st
roke
war
ning
: NSA
IDs,
exce
pt as
pirin
, inc
reas
e the
risk
of
hear
t atta
ck, h
eart
failu
re, a
nd st
roke
. The
se ca
n be
fata
l. Th
e risk
is h
ighe
r if y
ouus
e mor
e tha
n di
rect
ed o
r for
long
er th
an d
irect
ed.
Do n
ot u
seO
if yo
u ha
ve ev
er h
ad an
aller
gic r
eact
ion
to an
y oth
er p
ain re
lieve
r fev
er re
duce
r O
righ
t bef
ore o
r afte
r hea
rt su
rger
yAs
k a d
octo
r bef
ore
use
ifO
stom
ach
blee
ding
war
ning
appl
ies to
you
O yo
u ha
ve a
hist
ory o
f sto
mac
h pr
oblem
s, su
ch as
hea
rtbur
nO
you
have
hig
h bl
ood
pres
sure
, hea
rt di
seas
e, liv
er ci
rrhos
is, ki
dney
dise
ase,
asth
ma,
or h
ad a
stro
keO
you
are t
akin
g a d
iure
ticO
you
have
pro
blem
s or s
erio
us si
de ef
fect
s fro
m ta
king
pain
relie
vers
or f
ever
redu
cers
Ask a
doc
tor o
r pha
rmac
ist b
efor
e us
e if
you
are
O u
nder
a do
ctor
's ca
re fo
r any
serio
us co
nditi
onO
takin
g as
pirin
for h
eart
atta
ck o
r stro
ke, b
ecau
se n
apro
xen
may
dec
reas
e thi
sbe
nefit
of a
spiri
nO
takin
g an
y oth
er d
rug
Stop
use
and
ask
a d
octo
r if
O yo
u ex
perie
nce a
ny o
f the
follo
wing
sign
s of s
tom
ach
blee
ding
:O
feel
fain
t O
vom
it bl
ood O
hav
e blo
ody o
r blac
k sto
ols
O h
ave s
tom
ach
pain
that
doe
s not
get
bet
ter
O yo
u ha
ve sy
mpt
oms o
f hea
rt pr
oblem
s or s
troke
:O
ches
t pain
O
trou
ble b
reat
hing
O
wea
knes
s in
one p
art o
r sid
e of b
ody
O sl
urre
d sp
eech
O
leg
swe l
ing
O
pain
get
s wor
se o
r las
ts m
ore t
han
10 d
ays
O fe
ver g
ets w
orse
or l
asts
mor
e tha
n 3
days
O re
dnes
s or s
wellin
g is
pres
ent i
n th
e pain
ful a
rea
O an
y new
sym
ptom
s app
ear
O yo
u ha
ve d
ifficu
lty sw
a low
ing
O it
feels
like t
he ca
psul
e is s
tuck
in yo
ur th
roat
Drug
Fac
ts (c
ontin
ued)
If pr
egna
nt o
r bre
ast-f
eedi
ng, a
sk a
healt
h pr
ofes
siona
l bef
ore u
se. I
t is e
spec
ia ly
impo
rtant
not
to u
se n
apro
xen
sodi
um d
urin
g th
e las
t 3 m
onth
s of p
regn
ancy
unles
s def
inite
ly di
rect
ed to
do
so b
y a d
octo
r bec
ause
it m
ay ca
use p
robl
ems i
nth
e unb
orn
child
or c
ompl
icatio
ns d
urin
g de
liver
y.Ke
ep o
ut o
f rea
ch o
f chi
ldre
n. In
case
of o
verd
ose,
get m
edica
l help
or c
onta
ct a
Poiso
n Co
ntro
l Cen
ter r
ight
away
.
Dire
ctio
nsO
do
not t
ake
mor
e th
an d
irect
edO
he
smal
lest
effe
ctiv
e do
se sh
ould
be
used
O d
rink a
fu l g
lass o
f wat
er w
ith ea
ch d
ose
O if
take
n wi
th fo
od, t
his p
rodu
ct m
ay ta
ke lo
nger
to w
ork
Othe
r inf
orm
atio
nO
eac
h ca
psul
e co
ntai
ns: s
odiu
m 2
0 m
gO
stor
e at 2
0-25
°C (6
8-77
°F) a
void
hig
h hu
mid
ity an
d ex
cess
ive h
eat a
bove
40°C
(104
°F).
O P
rote
ct fr
om lig
ht.
O re
ad a
l dire
ctio
ns an
d wa
rnin
gs b
efor
e use
. Kee
p ca
rton.
Inac
tive
ingr
edie
nts
FD&C
blu
e #1,
gela
tin, g
lycer
in, l
actic
acid
, man
nito
l, ph
arm
aceu
tical
ink,
polye
thyle
ne g
lycol
, pov
idon
e, pr
opyle
ne g
lycol
, pur
ified
wat
er, s
orbi
tan,
sorb
itol
Ques
tions
or c
omm
ents
? 1-
888-
235-
2466
(Mon
- Fri
9AM
- 5P
M ES
T)
O ta
ke 1
caps
ule e
very
8 to
12
hour
s whi
le sy
mpt
oms l
ast
O fo
r the
firs
t dos
e you
may
take
2 ca
psul
es w
ithin
the f
irst h
our
O d
o no
t exc
eed
2 ca
psul
es in
any 8
- to
12-h
our p
erio
dO
do
not e
xcee
d 3
caps
ules
in a
24-h
our p
erio
d
adul
ts an
dch
ildre
n12
year
s and
olde
r:
child
ren
unde
r12
year
s: O
ask
a do
ctor
Whe
n us
ing
this
pro
duct
O ta
ke w
ith fo
od o
r milk
if st
omac
h up
set o
ccur
s
Do not use if printed safety seal under cap is torn or missing.
Lot N
o.:
Exp.
Date
:
R022
0L0
0000
00
Reference ID: 4601010
BIO
NPH
ARM
AL
ab
eli
ng
Fo
rma
t In
form
ati
on
:
Fo
nts
: Hel
vetic
a Co
nden
sed
Bold
, Hel
vetic
a Co
nden
sed,
H
elve
tica
Cond
ense
d Bo
ld O
bliq
ue
Dru
g F
ac
ts:
8pt
He
ad
er:
7pt
S
ub
he
ad
er:
6p
t B
od
y T
ex
t:
6pt
Dru
g F
ac
ts (c
ontin
ued)
: 7p
t
Hor
izon
tal S
cale
: 100
%
Aver
age
Kern
ing:
0%
Le
ad
ing
: 7.
2pt
Bu
lle
ts:
5pt
B
arl
ine
s:
.6pt
H
air
lin
es:
.2
pt
THIS
PACK
AGE F
OR HO
USEH
OLDS
WITH
OUT Y
OUNG
CHILD
REN
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
ARTHRITIS CAPEASY OPEN
ARTH
RITI
S CA
PEA
SYOP
EN
Compare to the active ingredient of ALEVE® Liquid Gels***
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg (NSAID)
Strength to last 12 hours
80 CAPSULES
NDC 69452-179-78
Napr
oxen
Sod
ium
Caps
ules
, 220
mg
(NSA
ID)
Pain
Rel
ieve
r/Fev
er R
educ
er
80 C
APSU
LES
Stre
ngth
to la
st 1
2 ho
urs
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg(NSAID)
Man
ufac
ture
d fo
r:Bi
onph
arm
a In
c.60
0 Al
exan
der R
oad,
Prin
ceto
n, N
J 08
540
Drug
Fac
tsAc
tive
ingr
edie
nt (i
n ea
ch ca
psul
e)
Purp
oses
Na
prox
en so
dium
220
mg
(nap
roxe
n 20
0 m
g) (N
SAID
)*.. .
... ....
..... .
... ....
.... ..
... ....
.... ..
... Pa
in re
lieve
r fev
er re
duce
r *n
onste
roida
l ant
i-inf
lamm
atory
dru
g
Uses
O te
mpo
raril
y reli
eves
min
or ac
hes a
nd p
ains d
ue to
:O
min
or p
ain o
f arth
ritis O
mus
cular
ache
s O
bac
kach
e O
men
stru
al cr
amps
O
hea
dach
e O
toot
hach
e O
the c
omm
on co
ldO
tem
pora
rily r
educ
es fe
ver
War
ning
sAl
lerg
y ale
rt: N
apro
xen
sodi
um m
ay ca
use a
seve
re a
lergi
c rea
ctio
n, es
pecia
lly in
pe
ople
aller
gic t
o as
pirin
. Sym
ptom
s may
inclu
de:
O h
ives O
facia
l swe
lling O
asth
ma (
whee
zing)
O s
hock
O
skin
redd
enin
g O
rash
O
blis
ters
If an
aller
gic r
eact
ion
occu
rs, s
top
use a
nd se
ek m
edica
l help
righ
t awa
y.St
omac
h bl
eedi
ng w
arni
ng: T
his p
rodu
ct co
ntain
s an
NSAI
D, w
hich
may
caus
ese
vere
stom
ach
blee
ding
. The
chan
ce is
hig
her i
f you
:O
are a
ge 6
0 or
old
erO
hav
e had
stom
ach
ulce
rs o
r blee
ding
pro
blem
sO
take
a bl
ood
thin
ning
(ant
icoag
ulan
t) or
ster
oid
drug
O ta
ke o
ther
dru
gs co
ntain
ing
pres
crip
tion
or n
onpr
escr
iptio
n NS
AIDs
(asp
irin,
ibup
rofe
n, n
apro
xen,
or o
ther
s)O
hav
e 3 o
r mor
e alco
holic
drin
ks ev
ery d
ay w
hile
usin
g th
is pr
oduc
tO
take
mor
e or f
or a
long
er ti
me t
han
dire
cted
Hear
t atta
ck a
nd st
roke
war
ning
: NSA
IDs,
exce
pt as
pirin
, inc
reas
e the
risk
of
hear
t atta
ck, h
eart
failu
re, a
nd st
roke
. The
se ca
n be
fata
l. Th
e risk
is h
ighe
r if y
ouus
e mor
e tha
n di
rect
ed o
r for
long
er th
an d
irect
ed.
Do n
ot u
seO
if yo
u ha
ve ev
er h
ad an
aller
gic r
eact
ion
to an
y oth
er p
ain re
lieve
r fev
er re
duce
r O
righ
t bef
ore o
r afte
r hea
rt su
rger
yAs
k a d
octo
r bef
ore
use
ifO
stom
ach
blee
ding
war
ning
appl
ies to
you
O yo
u ha
ve a
hist
ory o
f sto
mac
h pr
oblem
s, su
ch as
hea
rtbur
nO
you
have
hig
h bl
ood
pres
sure
, hea
rt di
seas
e, liv
er ci
rrhos
is, ki
dney
dise
ase,
asth
ma,
or h
ad a
stro
keO
you
are t
akin
g a d
iure
ticO
you
have
pro
blem
s or s
erio
us si
de ef
fect
s fro
m ta
king
pain
relie
vers
or f
ever
redu
cers
Ask a
doc
tor o
r pha
rmac
ist b
efor
e us
e if
you
are
O u
nder
a do
ctor
's ca
re fo
r any
serio
us co
nditi
onO
takin
g as
pirin
for h
eart
atta
ck o
r stro
ke, b
ecau
se n
apro
xen
may
dec
reas
e thi
sbe
nefit
of a
spiri
nO
takin
g an
y oth
er d
rug
Whe
n us
ing
this
pro
duct
O ta
ke w
ith fo
od o
r milk
if st
omac
h up
set o
ccur
s
Do not use if printed safety seal under cap is torn or missing.
Lot N
o.:
Exp.
Date
:
***T
his
prod
uct i
s no
t man
ufac
ture
d or
dis
tribu
ted
by th
e ow
ners
of A
LEVE
® L
iqui
d Ge
ls.
R022
0L0
0000
00
Stop
use
and
ask
a d
octo
r if
O yo
u ex
perie
nce a
ny o
f the
follo
wing
sign
s of s
tom
ach
blee
ding
:O
feel
fain
t O
vom
it bl
ood O
hav
e blo
ody o
r blac
k sto
ols
O h
ave s
tom
ach
pain
that
doe
s not
get
bet
ter
O yo
u ha
ve sy
mpt
oms o
f hea
rt pr
oblem
s or s
troke
:O
ches
t pain
O
trou
ble b
reat
hing
O
wea
knes
s in
one p
art o
r sid
e of b
ody
O sl
urre
d sp
eech
O
leg
swe l
ing
O
pain
get
s wor
se o
r las
ts m
ore t
han
10 d
ays
O fe
ver g
ets w
orse
or l
asts
mor
e tha
n 3
days
O re
dnes
s or s
wellin
g is
pres
ent i
n th
e pain
ful a
rea
O an
y new
sym
ptom
s app
ear
O yo
u ha
ve d
ifficu
lty sw
a low
ing
O it
feels
like t
he ca
psul
e is s
tuck
in yo
ur th
roat
Drug
Fac
ts (c
ontin
ued)
If pr
egna
nt o
r bre
ast-f
eedi
ng, a
sk a
healt
h pr
ofes
siona
l bef
ore u
se. I
t is e
spec
ia ly
impo
rtant
not
to u
se n
apro
xen
sodi
um d
urin
g th
e las
t 3 m
onth
s of p
regn
ancy
unles
s def
inite
ly di
rect
ed to
do
so b
y a d
octo
r bec
ause
it m
ay ca
use p
robl
ems i
nth
e unb
orn
child
or c
ompl
icatio
ns d
urin
g de
liver
y.Ke
ep o
ut o
f rea
ch o
f chi
ldre
n. In
case
of o
verd
ose,
get m
edica
l help
or c
onta
ct a
Poiso
n Co
ntro
l Cen
ter r
ight
away
.
Dire
ctio
nsO
do
not t
ake
mor
e th
an d
irect
edO
he
smal
lest
effe
ctiv
e do
se sh
ould
be
used
O d
rink a
fu l g
lass o
f wat
er w
ith ea
ch d
ose
O if
take
n wi
th fo
od, t
his p
rodu
ct m
ay ta
ke lo
nger
to w
ork
Othe
r inf
orm
atio
nO
eac
h ca
psul
e co
ntai
ns: s
odiu
m 2
0 m
gO
stor
e at 2
0-25
°C (6
8-77
°F) a
void
hig
h hu
mid
ity an
d ex
cess
ive h
eat a
bove
40°C
(104
°F).
O P
rote
ct fr
om lig
ht.
O re
ad a
l dire
ctio
ns an
d wa
rnin
gs b
efor
e use
. Kee
p ca
rton.
Inac
tive
ingr
edie
nts
FD&C
blu
e #1,
gela
tin, g
lycer
in, l
actic
acid
, man
nito
l, ph
arm
aceu
tical
ink,
polye
thyle
ne g
lycol
, pov
idon
e, pr
opyle
ne g
lycol
, pur
ified
wat
er, s
orbi
tan,
sorb
itol
Ques
tions
or c
omm
ents
? 1-
888-
235-
2466
(Mon
- Fri
9AM
- 5P
M ES
T)
O ta
ke 1
caps
ule e
very
8 to
12
hour
s whi
le sy
mpt
oms l
ast
O fo
r the
firs
t dos
e you
may
take
2 ca
psul
es w
ithin
the f
irst h
our
O d
o no
t exc
eed
2 ca
psul
es in
any 8
- to
12-h
our p
erio
dO
do
not e
xcee
d 3
caps
ules
in a
24-h
our p
erio
d
adul
ts an
dch
ildre
n12
year
s and
olde
r:
child
ren
unde
r12
year
s: O
ask
a do
ctor
Reference ID: 4601010
)))
100 CAPSULES
Actual Size
Drug
Fac
tsAc
tive
ingr
edie
nt (i
n ea
ch ca
psul
e)
Purp
oses
Na
prox
en so
dium
220
mg
(nap
roxe
n 20
0 m
g) (N
SAID
)*....
.... ..
.. ... .
... ....
.... ..
.Pain
relie
ver f
ever
redu
cer
*non
stero
idal a
nti-i
nflam
mato
ry d
rug
Uses
O te
mpo
raril
y reli
eves
min
or ac
hes a
nd p
ains d
ue to
:O
min
or p
ain o
f arth
ritis O
mus
cular
ache
s O
bac
kach
e O
men
stru
al cr
amps
O
hea
dach
e O
toot
hach
e O
the c
omm
on co
ldO
tem
pora
rily r
educ
es fe
ver
War
ning
sAl
lerg
y ale
rt: N
apro
xen
sodi
um m
ay ca
use a
seve
re al
lergi
c rea
ctio
n,es
pecia
lly in
peo
ple a
llerg
ic to
aspi
rin. S
ympt
oms m
ay in
clude
:O
hive
s O
facia
l swe
lling O
asth
ma (
whee
zing)
O s
hock
O
skin
redd
enin
g O
rash
O
blis
ters
If an
aller
gic r
eact
ion
occu
rs, s
top
use a
nd se
ek m
edica
l help
righ
t awa
y.St
omac
h bl
eedi
ng w
arni
ng: T
his p
rodu
ct co
ntain
s an
NSAI
D, w
hich
may
caus
e sev
ere s
tom
ach
blee
ding
. The
chan
ce is
hig
her i
f you
:O
are a
ge 6
0 or
old
erO
hav
e had
stom
ach
ulce
rs o
r blee
ding
pro
blem
sO
take
a bl
ood
thin
ning
(ant
icoag
ulan
t) or
ster
oid
drug
O ta
ke o
ther
dru
gs co
ntain
ing
pres
crip
tion
or n
onpr
escr
iptio
n NS
AIDs
(asp
irin,
ibup
rofe
n, n
apro
xen,
or o
ther
s)O
hav
e 3 o
r mor
e alco
holic
drin
ks ev
ery d
ay w
hile
usin
g th
is pr
oduc
tO
take
mor
e or f
or a
long
er ti
me t
han
dire
cted
Hear
t atta
ck a
nd st
roke
war
ning
: NSA
IDs,
exce
pt as
pirin
, inc
reas
e the
risk
of h
eart
atta
ck, h
eart
failu
re, a
nd st
roke
. The
se ca
n be
fata
l. Th
e risk
ishi
gher
if yo
u us
e mor
e tha
n di
rect
ed o
r for
long
er th
an d
irect
ed.
Do n
ot u
seO
if yo
u ha
ve ev
er h
ad an
a ler
gic r
eact
ion
to an
y oth
er p
ain re
lieve
r fev
er
redu
cer
O ri
ght b
efor
e or a
fter h
eart
surg
ery
Ask a
doc
tor b
efor
e us
e f
O st
omac
h bl
eedi
ng w
arni
ng ap
plies
to yo
uO
you
have
a hi
stor
y of s
tom
ach
prob
lems,
such
as h
eartb
urn
O yo
u ha
ve h
igh
bloo
d pr
essu
re, h
eart
dise
ase,
liver
cirrh
osis,
kidn
eydi
seas
e, as
thm
a, or
had
a st
roke
O yo
u ar
e tak
ing
a diu
retic
O yo
u ha
ve p
robl
ems o
r ser
ious
side
effe
cts f
rom
takin
g pa
in re
lieve
rs o
rfe
ver r
educ
ers
Do not use if printed safety seal under cap istorn or missing.
recudeRreveF/reveileRniaP
muidoSnexorpaNgm022,seluspaC
)DIASN(
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg (NSAID)
Strength to last 12 hours
NDC 69452 179 20
100 CAPSULES
Actual Size
Man
ufac
ture
d fo
r:BI
ON
PHAR
MA
600
Alex
ande
r Roa
d,Pr
ince
ton,
NJ
0854
0
Lot N
o.:
Exp.
Date
:
R022
0L0
0000
00
Drug
Fac
ts (c
ontin
ued)
Stop
use
and
ask
a d
octo
r if
O yo
u ex
perie
nce a
ny o
f the
follo
wing
sign
s of s
tom
ach
blee
ding
:O
feel
fain
t O
vom
it bl
ood O
hav
e blo
ody o
r blac
k sto
ols
O h
ave s
tom
ach
pain
that
doe
s not
get
bet
ter
O yo
u ha
ve sy
mpt
oms o
f hea
rt pr
oblem
s or s
troke
:O
ches
t pain
O
trou
ble b
reat
hing
O w
eakn
ess i
n on
e par
t or s
ide o
f bod
yO
slur
red
spee
ch O
leg
swell
ing
O p
ain g
ets w
orse
or l
asts
mor
e tha
n 10
day
sO
feve
r get
s wor
se o
r las
ts m
ore t
han
3 da
ysO
redn
ess o
r swe
lling
is pr
esen
t in
the p
ainfu
l are
aO
any n
ew sy
mpt
oms a
ppea
rO
you
have
diff
iculty
swall
owing
O it
feels
like t
he ca
psul
e is s
tuck
in yo
ur th
roat
If pr
egna
nt o
r bre
ast-f
eedi
ng, a
sk a
hea t
h pr
ofes
siona
l bef
ore u
se. I
t is
espe
cially
impo
rtant
not
to u
se n
apro
xen
sodi
um d
urin
g th
e las
t 3 m
onth
sof
pre
gnan
cy u
nles
s def
inite
ly di
rect
ed to
do
so b
y a d
octo
r bec
ause
it m
ayca
use p
robl
ems i
n th
e unb
orn
child
or c
ompl
icatio
ns d
urin
g de
liver
y.Ke
ep o
ut o
f rea
ch o
f chi
ldre
n. In
case
of o
verd
ose,
get m
edica
l help
or
cont
act a
Poi
son
Cont
rol C
ente
r rig
ht aw
ay.
Dire
ctio
nsO
do
not t
ake
mor
e th
an d
irect
edO
the
smal
lest
effe
c iv
e do
se sh
ould
be
used
O
drin
k a fu
ll glas
s of w
ater
with
each
dos
eO
if ta
ken
with
food
, thi
s pro
duct
may
take
long
er to
wor
kO
take
1 ca
psul
e eve
ry 8
to
2 ho
urs w
hile
sym
ptom
s las
t O
for t
he fi
rst d
ose y
ou m
ay ta
ke 2
caps
ules
with
in th
efir
st h
our
O d
o no
t exc
eed
2 ca
psul
es in
any 8
- to
12-h
our p
erio
dO
do
not e
xcee
d 3
caps
ules
in a
24-h
our p
erio
d
adul
ts an
dch
ildre
n12
year
s and
olde
r:
ch ld
ren
unde
r 12
year
s: O
ask
a do
ctor
Ask a
doc
tor o
r pha
rmac
ist b
efor
e us
e if
you
are
O u
nder
a do
ctor
's ca
re fo
r any
serio
us co
nditi
onO
takin
g as
pirin
for h
eart
atta
ck o
r stro
ke, b
ecau
se n
apro
xen
may
decr
ease
this
bene
fit o
f asp
irin
O ta
king
any o
ther
dru
g
Whe
n us
ing
this
pro
duct
O ta
ke w
ith fo
od o
r milk
if st
omac
h up
set o
ccur
s
Drug
Fac
ts (c
ontin
ued)
Othe
r inf
orm
atio
nO
eac
h ca
psul
e co
ntai
ns: s
odiu
m 2
0 m
gO
stor
e at 2
0-25
°C (6
8-77
°F) a
void
hig
h hu
mid
ity an
d ex
cess
ive h
eat a
bove
40°C
(104
°F).
O P
rotec
t from
light.
O re
ad al
l dire
ctio
ns an
d wa
rnin
gs b
efor
e use
. Kee
p ca
rton.
Inac
tive
ingr
edie
nts
FD&C
blu
e #1,
gela
tin, g
lycer
in, l
actic
acid
, man
nito
l, ph
arm
aceu
tical
ink,
polye
thyle
ne g
lycol
, pov
idon
e, pr
opyle
ne g
lycol
, pur
ified
wat
er, s
orbi
tan,
sorb
itol
Ques
tions
or c
omm
ents
? 1-
888-
235-
2466
(Mon
- Fri
9AM
- 5P
M ES
T)
BIO
NPH
ARM
AL
ab
eli
ng
Fo
rma
t In
form
ati
on
:
Fo
nts
: Hel
vetic
a Co
nden
sed
Bold
, Hel
vetic
a Co
nden
sed,
H
elve
tica
Cond
ense
d Bo
ld O
bliq
ue
Dru
g F
ac
ts:
8pt
He
ad
er:
7pt
S
ub
he
ad
er:
6p
t B
od
y T
ex
t:
6pt
Dru
g F
ac
ts (c
ontin
ued)
: 7p
t
Hor
izon
tal S
cale
: 100
%
Aver
age
Kern
ing:
0%
Le
ad
ing
: 7.
2pt
Bu
lle
ts:
5pt
B
arl
ine
s:
.6pt
H
air
lin
es:
.2
pt
Reference ID: 4601010
)))
100 CAPSULES
Actual Size
Drug
Fac
tsAc
tive
ingr
edie
nt (i
n ea
ch ca
psul
e)
Purp
oses
Na
prox
en so
dium
220
mg
(nap
roxe
n 20
0 m
g) (N
SAID
)*....
.... ..
.. ... .
... ....
.... ..
.Pain
relie
ver f
ever
redu
cer
*non
stero
idal a
nti-i
nflam
mato
ry d
rug
Uses
O te
mpo
raril
y reli
eves
min
or ac
hes a
nd p
ains d
ue to
:O
min
or p
ain o
f arth
ritis O
mus
cular
ache
s O
bac
kach
e O
men
stru
al cr
amps
O
hea
dach
e O
toot
hach
e O
the c
omm
on co
ldO
tem
pora
rily r
educ
es fe
ver
War
ning
sAl
lerg
y ale
rt: N
apro
xen
sodi
um m
ay ca
use a
seve
re al
lergi
c rea
ctio
n,es
pecia
lly in
peo
ple a
llerg
ic to
aspi
rin. S
ympt
oms m
ay in
clude
:O
hive
s O
facia
l swe
lling O
asth
ma (
whee
zing)
O s
hock
O
skin
redd
enin
g O
rash
O
blis
ters
If an
aller
gic r
eact
ion
occu
rs, s
top
use a
nd se
ek m
edica
l help
righ
t awa
y.St
omac
h bl
eedi
ng w
arni
ng: T
his p
rodu
ct co
ntain
s an
NSAI
D, w
hich
may
caus
e sev
ere s
tom
ach
blee
ding
. The
chan
ce is
hig
her i
f you
:O
are a
ge 6
0 or
old
erO
hav
e had
stom
ach
ulce
rs o
r blee
ding
pro
blem
sO
take
a bl
ood
thin
ning
(ant
icoag
ulan
t) or
ster
oid
drug
O ta
ke o
ther
dru
gs co
ntain
ing
pres
crip
tion
or n
onpr
escr
iptio
n NS
AIDs
(asp
irin,
ibup
rofe
n, n
apro
xen,
or o
ther
s)O
hav
e 3 o
r mor
e alco
holic
drin
ks ev
ery d
ay w
hile
usin
g th
is pr
oduc
tO
take
mor
e or f
or a
long
er ti
me t
han
dire
cted
Hear
t atta
ck a
nd st
roke
war
ning
: NSA
IDs,
exce
pt as
pirin
, inc
reas
e the
risk
of h
eart
atta
ck, h
eart
failu
re, a
nd st
roke
. The
se ca
n be
fata
l. Th
e risk
ishi
gher
if yo
u us
e mor
e tha
n di
rect
ed o
r for
long
er th
an d
irect
ed.
Do n
ot u
seO
if yo
u ha
ve ev
er h
ad an
a ler
gic r
eact
ion
to an
y oth
er p
ain re
lieve
r fev
er
redu
cer
O ri
ght b
efor
e or a
fter h
eart
surg
ery
Ask a
doc
tor b
efor
e us
e f
O st
omac
h bl
eedi
ng w
arni
ng ap
plies
to yo
uO
you
have
a hi
stor
y of s
tom
ach
prob
lems,
such
as h
eartb
urn
O yo
u ha
ve h
igh
bloo
d pr
essu
re, h
eart
dise
ase,
liver
cirrh
osis,
kidn
eydi
seas
e, as
thm
a, or
had
a st
roke
O yo
u ar
e tak
ing
a diu
retic
O yo
u ha
ve p
robl
ems o
r ser
ious
side
effe
cts f
rom
takin
g pa
in re
lieve
rs o
rfe
ver r
educ
ers
Do not use if printed safety seal under cap istorn or missing.
recudeRreveF/reveileRniaP
muidoSnexorpaNgm022,seluspaC
)DIASN(
Compare to the active ingredient of ALEVE ® Liquid Gels***
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg (NSAID)
Strength to last 12 hours
NDC 69452 179 20
100 CAPSULES
Actual Size
Man
ufac
ture
d fo
r:BI
ON
PHAR
MA
600
Alex
ande
r Roa
d,Pr
ince
ton,
NJ
0854
0
Lot N
o.:
Exp.
Date
:
R022
0L0
0000
00
Drug
Fac
ts (c
ontin
ued)
Stop
use
and
ask
a d
octo
r if
O yo
u ex
perie
nce a
ny o
f the
follo
wing
sign
s of s
tom
ach
blee
ding
:O
feel
fain
t O
vom
it bl
ood O
hav
e blo
ody o
r blac
k sto
ols
O h
ave s
tom
ach
pain
that
doe
s not
get
bet
ter
O yo
u ha
ve sy
mpt
oms o
f hea
rt pr
oblem
s or s
troke
:O
ches
t pain
O
trou
ble b
reat
hing
O w
eakn
ess i
n on
e par
t or s
ide o
f bod
yO
slur
red
spee
ch O
leg
swell
ing
O p
ain g
ets w
orse
or l
asts
mor
e tha
n 10
day
sO
feve
r get
s wor
se o
r las
ts m
ore t
han
3 da
ysO
redn
ess o
r swe
lling
is pr
esen
t in
the p
ainfu
l are
aO
any n
ew sy
mpt
oms a
ppea
rO
you
have
diff
iculty
swall
owing
O it
feels
like t
he ca
psul
e is s
tuck
in yo
ur th
roat
If pr
egna
nt o
r bre
ast-f
eedi
ng, a
sk a
hea t
h pr
ofes
siona
l bef
ore u
se. I
t is
espe
cially
impo
rtant
not
to u
se n
apro
xen
sodi
um d
urin
g th
e las
t 3 m
onth
sof
pre
gnan
cy u
nles
s def
inite
ly di
rect
ed to
do
so b
y a d
octo
r bec
ause
it m
ayca
use p
robl
ems i
n th
e unb
orn
child
or c
ompl
icatio
ns d
urin
g de
liver
y.Ke
ep o
ut o
f rea
ch o
f chi
ldre
n. In
case
of o
verd
ose,
get m
edica
l help
or
cont
act a
Poi
son
Cont
rol C
ente
r rig
ht aw
ay.
Dire
ctio
nsO
do
not t
ake
mor
e th
an d
irect
edO
the
smal
lest
effe
c iv
e do
se sh
ould
be
used
O
drin
k a fu
ll glas
s of w
ater
with
each
dos
eO
if ta
ken
with
food
, thi
s pro
duct
may
take
long
er to
wor
kO
take
1 ca
psul
e eve
ry 8
to
2 ho
urs w
hile
sym
ptom
s las
t O
for t
he fi
rst d
ose y
ou m
ay ta
ke 2
caps
ules
with
in th
efir
st h
our
O d
o no
t exc
eed
2 ca
psul
es in
any 8
- to
12-h
our p
erio
dO
do
not e
xcee
d 3
caps
ules
in a
24-h
our p
erio
d
adul
ts an
dch
ildre
n12
year
s and
olde
r:
ch ld
ren
unde
r 12
year
s: O
ask
a do
ctor
Ask a
doc
tor o
r pha
rmac
ist b
efor
e us
e if
you
are
O u
nder
a do
ctor
's ca
re fo
r any
serio
us co
nditi
onO
takin
g as
pirin
for h
eart
atta
ck o
r stro
ke, b
ecau
se n
apro
xen
may
decr
ease
this
bene
fit o
f asp
irin
O ta
king
any o
ther
dru
g
Whe
n us
ing
this
pro
duct
O ta
ke w
ith fo
od o
r milk
if st
omac
h up
set o
ccur
s
***T
his
prod
uct i
s no
t man
ufac
ture
d or
dist
ribut
ed b
y th
e ow
ners
of A
LEVE
® L
iqui
d Ge
ls.
Drug
Fac
ts (c
ontin
ued)
Othe
r inf
orm
atio
nO
eac
h ca
psul
e co
ntai
ns: s
odiu
m 2
0 m
gO
stor
e at 2
0-25
°C (6
8-77
°F) a
void
hig
h hu
mid
ity an
d ex
cess
ive h
eat a
bove
40°C
(104
°F).
O P
rotec
t from
light.
O re
ad al
l dire
ctio
ns an
d wa
rnin
gs b
efor
e use
. Kee
p ca
rton.
Inac
tive
ingr
edie
nts
FD&C
blu
e #1,
gela
tin, g
lycer
in, l
actic
acid
, man
nito
l, ph
arm
aceu
tical
ink,
polye
thyle
ne g
lycol
, pov
idon
e, pr
opyle
ne g
lycol
, pur
ified
wat
er, s
orbi
tan,
sorb
itol
Ques
tions
or c
omm
ents
? 1-
888-
235-
2466
(Mon
- Fri
9AM
- 5P
M ES
T)
BIO
NPH
ARM
AL
ab
eli
ng
Fo
rma
t In
form
ati
on
:
Fo
nts
: Hel
vetic
a Co
nden
sed
Bold
, Hel
vetic
a Co
nden
sed,
H
elve
tica
Cond
ense
d Bo
ld O
bliq
ue
Dru
g F
ac
ts:
8pt
He
ad
er:
7pt
S
ub
he
ad
er:
6p
t B
od
y T
ex
t:
6pt
Dru
g F
ac
ts (c
ontin
ued)
: 7p
t
Hor
izon
tal S
cale
: 100
%
Aver
age
Kern
ing:
0%
Le
ad
ing
: 7.
2pt
Bu
lle
ts:
5pt
B
arl
ine
s:
.6pt
H
air
lin
es:
.2
pt
Reference ID: 4601010
120 CAPSULES
Actual Size
120 CAPSULES
Actual Size
Drug
Fac
tsAc
tive
ingr
edie
nt (i
n ea
ch ca
psul
e)
Purp
oses
Na
prox
en so
dium
220
mg
(nap
roxe
n 20
0 m
g) (N
SAID
)*...
... .. .
.. ... .
.. ... .
.. ... .
.. ... .
.. ..P
ain re
lieve
r fev
er re
duce
r *n
onste
roida
l ant
i-inf
lamm
atory
dru
g
Uses
O te
mpo
raril
y reli
eves
min
or ac
hes a
nd p
ains d
ue to
:O
min
or p
ain o
f arth
ritis O
mus
cular
ache
s O
bac
kach
e O
men
stru
al cr
amps
O
hea
dach
e O
toot
hach
e O
the c
omm
on co
ldO
tem
pora
rily r
educ
es fe
ver
War
ning
sAl
lerg
y ale
rt: N
apro
xen
sodi
um m
ay ca
use a
seve
re al
lergi
c rea
ctio
n, es
pecia
lly in
peop
le a l
ergi
c to
aspi
rin. S
ympt
oms m
ay in
clude
: O
hive
s O
facia
l swe
lling O
asth
ma (
whee
zing)
O s
hock
O
skin
redd
enin
g O
rash
O
blis
ters
If an
aller
gic r
eact
ion
occu
rs, s
top
use a
nd se
ek m
edica
l help
righ
t awa
y.St
omac
h bl
eedi
ng w
arni
ng: T
his p
rodu
ct co
ntain
s an
NSA
D, w
hich
may
caus
e se
vere
stom
ach
blee
ding
. The
chan
ce is
hig
her i
f you
:O
are a
ge 6
0 or
old
erO
hav
e had
stom
ach
ulce
rs o
r blee
ding
pro
blem
sO
take
a bl
ood
thin
ning
(ant
icoag
ulan
t) or
ster
oid
drug
O ta
ke o
ther
dru
gs co
ntain
ing
pres
crip
tion
or n
onpr
escr
iptio
n NS
AIDs
(asp
irin,
ibup
rofe
n, n
apro
xen,
or o
ther
s)O
hav
e 3 o
r mor
e alco
holic
drin
ks ev
ery d
ay w
hile
usin
g th
is pr
oduc
tO
take
mor
e or f
or a
long
er ti
me t
han
dire
cted
Hear
t a ta
ck a
nd st
roke
war
ning
: NSA
IDs,
exce
pt as
pirin
, inc
reas
e the
risk
of
hear
t atta
ck, h
eart
failu
re, a
nd st
roke
. The
se ca
n be
fata
l. Th
e risk
is h
ighe
r if y
ouus
e mor
e tha
n di
rect
ed o
r for
long
er th
an d
irect
ed.
Do n
ot u
seO
if yo
u ha
ve ev
er h
ad an
a ler
gic r
eact
ion
to an
y oth
er p
ain re
lieve
r fev
er re
duce
r O
righ
t bef
ore o
r a te
r hea
rt su
rger
yAs
k a d
octo
r bef
ore
use
ifO
stom
ach
blee
ding
war
ning
appl
ies to
you
O yo
u ha
ve a
hist
ory o
f sto
mac
h pr
oblem
s, su
ch as
hea
rtbur
nO
you
have
hig
h bl
ood
pres
sure
, hea
rt di
seas
e, liv
er ci
rrhos
is, ki
dney
dise
ase,
asth
ma,
or h
ad a
stro
keO
you
are t
akin
g a d
iure
ticO
you
have
pro
blem
s or s
erio
us si
de ef
fect
s fro
m ta
king
pain
relie
vers
or f
ever
redu
cers
Ask a
doc
tor o
r pha
rmac
ist b
efor
e us
e f y
ou a
reO
und
er a
doct
or's
care
for a
ny se
rious
cond
ition
O ta
king
aspi
rin fo
r hea
rt at
tack
or s
troke
, bec
ause
nap
roxe
n m
ay d
ecre
ase t
his
bene
fit o
f asp
irin
O ta
king
any o
ther
dru
g
Whe
n us
ing
this
pro
duct
O ta
ke w
ith fo
od o
r milk
if st
omac
h up
set o
ccur
s
Do not use if printed safety seal under cap istorn or missing.
recudeRreveF/reveileRniaP
muidoSnexorpaNgm022,seluspaC
)DIASN(Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg (NSAID)
Strength to last 12 hours
Lot N
o.:
Exp.
Date
:
120 CAPSULES
Actual Size
NDC 69452 179 22
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg (NSAID)
Strength to last 12 hours 120 CAPSULES
Actual Size
NDC 69452 179 22
R022
0L0
0000
00
Man
ufac
ture
d fo
r:BI
ON
PHAR
MA
600
Alex
ande
r Roa
d,Pr
ince
ton,
NJ
0854
0
Stop
use
and
ask
a d
octo
r if
O yo
u ex
perie
nce a
ny o
f the
fo lo
wing
sign
s of s
tom
ach
blee
ding
:O
feel
fain
t O
vom
it bl
ood O
hav
e blo
ody o
r blac
k sto
ols
O h
ave s
tom
ach
pain
that
doe
s not
get
bet
ter
O yo
u ha
ve sy
mpt
oms o
f hea
rt pr
oblem
s or s
troke
:O
ches
t pain
O
trou
ble b
reat
hing
O
wea
knes
s in
one p
art o
r sid
e of b
ody
O sl
urre
d sp
eech
O
leg
swell
ing
O p
ain g
ets w
orse
or l
asts
mor
e tha
n 0
days
O fe
ver g
ets w
orse
or l
asts
mor
e tha
n 3
days
O re
dnes
s or s
wellin
g is
pres
ent i
n th
e pain
ful a
rea
O an
y new
sym
ptom
s app
ear
O yo
u ha
ve d
ifficu
lty sw
a low
ing
O it
feels
like t
he ca
psul
e is s
tuck
in yo
ur th
roat
Drug
Fac
ts (c
ont n
ued)
If pr
egna
nt o
r bre
ast-f
eedi
ng, a
sk a
healt
h pr
ofes
s ona
l bef
ore u
se. I
t is e
spec
ially
impo
rtant
not
to u
se n
apro
xen
sodi
um d
urin
g th
e las
t 3 m
onth
s of p
regn
ancy
unles
s def
inite
ly di
rect
ed to
do
so b
y a d
octo
r bec
ause
it m
ay ca
use p
robl
ems i
nth
e unb
orn
child
or c
ompl
icatio
ns d
urin
g de
liver
y.Ke
ep o
ut o
f rea
ch o
f chi
ldre
n. In
case
of o
verd
ose,
get m
edica
l help
or c
onta
ct a
Poiso
n Co
ntro
l Cen
ter r
ight
away
.
Dire
ctio
nsO
do
not t
ake
mor
e th
an d
irect
edO
the
smal
lest
effe
c iv
e do
se sh
ould
be
used
O
drin
k a fu
ll glas
s of w
ater
with
each
dos
eO
if ta
ken
with
food
, thi
s pro
duct
may
take
long
er to
wor
k
Othe
r inf
orm
atio
nO
eac
h ca
psul
e co
ntai
ns: s
odiu
m 2
0 m
gO
stor
e at 2
0-25
°C (6
8-77
°F) a
void
hig
h hu
mid
ity an
d ex
cess
ive h
eat a
bove
40°C
(104
°F).
O P
rote
ct fr
om lig
ht.
O re
ad a
l dire
ctio
ns an
d wa
rnin
gs b
efor
e use
. Kee
p ca
rton.
Inac
tive
ingr
edie
nts
FD&C
blu
e #1,
gela
tin, g
lycer
in, l
actic
acid
, man
nito
l, ph
arm
aceu
tical
ink,
polye
thyle
ne g
lycol
, pov
idon
e, pr
opyle
ne g
lycol
, pur
ified
wat
er, s
orbi
tan,
sorb
itol
O ta
ke 1
caps
ule e
very
8 to
2
hour
s wh
le sy
mpt
oms l
ast
O fo
r the
firs
t dos
e you
may
take
2 ca
psul
es w
ithin
the f
irst h
our
O d
o no
t exc
eed
2 ca
psul
es in
any 8
- to
2-ho
ur p
erio
dO
do
not e
xcee
d 3
caps
ules
in a
24-h
our p
erio
d
adul
ts an
dch
ildre
n12
year
s and
olde
r:
child
ren
unde
r12
year
s: O
ask
a do
ctor
Ques
tions
or c
omm
ents
? 1-
888-
235-
2466
(Mon
- Fri
9AM
- 5P
M ES
T)
BIO
NPH
ARM
AL
ab
eli
ng
Fo
rma
t In
form
ati
on
:
Fo
nts
: Hel
vetic
a Co
nden
sed
Bold
, Hel
vetic
a Co
nden
sed,
H
elve
tica
Cond
ense
d Bo
ld O
bliq
ue
Dru
g F
ac
ts:
8pt
He
ad
er:
7pt
S
ub
he
ad
er:
6p
t B
od
y T
ex
t:
6pt
Dru
g F
ac
ts (c
ontin
ued)
: 7p
t
Hor
izon
tal S
cale
: 100
%
Aver
age
Kern
ing:
0%
Le
ad
ing
: 7.
2pt
Bu
lle
ts:
5pt
B
arl
ine
s:
.6pt
H
air
lin
es:
.2
pt
Reference ID: 4601010
120 CAPSULES
Actual Size
120 CAPSULES
Actual Size
Drug
Fac
tsAc
tive
ingr
edie
nt (i
n ea
ch ca
psul
e)
Purp
oses
Na
prox
en so
dium
220
mg
(nap
roxe
n 20
0 m
g) (N
SAID
)*...
... .. .
.. ... .
.. ... .
.. ... .
.. ... .
.. ..P
ain re
lieve
r fev
er re
duce
r *n
onste
roida
l ant
i-inf
lamm
atory
dru
g
Uses
O te
mpo
raril
y reli
eves
min
or ac
hes a
nd p
ains d
ue to
:O
min
or p
ain o
f arth
ritis O
mus
cular
ache
s O
bac
kach
e O
men
stru
al cr
amps
O
hea
dach
e O
toot
hach
e O
the c
omm
on co
ldO
tem
pora
rily r
educ
es fe
ver
War
ning
sAl
lerg
y ale
rt: N
apro
xen
sodi
um m
ay ca
use a
seve
re al
lergi
c rea
ctio
n, es
pecia
lly in
peop
le a l
ergi
c to
aspi
rin. S
ympt
oms m
ay in
clude
: O
hive
s O
facia
l swe
lling O
asth
ma (
whee
zing)
O s
hock
O
skin
redd
enin
g O
rash
O
blis
ters
If an
aller
gic r
eact
ion
occu
rs, s
top
use a
nd se
ek m
edica
l help
righ
t awa
y.St
omac
h bl
eedi
ng w
arni
ng: T
his p
rodu
ct co
ntain
s an
NSA
D, w
hich
may
caus
e se
vere
stom
ach
blee
ding
. The
chan
ce is
hig
her i
f you
:O
are a
ge 6
0 or
old
erO
hav
e had
stom
ach
ulce
rs o
r blee
ding
pro
blem
sO
take
a bl
ood
thin
ning
(ant
icoag
ulan
t) or
ster
oid
drug
O ta
ke o
ther
dru
gs co
ntain
ing
pres
crip
tion
or n
onpr
escr
iptio
n NS
AIDs
(asp
irin,
ibup
rofe
n, n
apro
xen,
or o
ther
s)O
hav
e 3 o
r mor
e alco
holic
drin
ks ev
ery d
ay w
hile
usin
g th
is pr
oduc
tO
take
mor
e or f
or a
long
er ti
me t
han
dire
cted
Hear
t a ta
ck a
nd st
roke
war
ning
: NSA
IDs,
exce
pt as
pirin
, inc
reas
e the
risk
of
hear
t atta
ck, h
eart
failu
re, a
nd st
roke
. The
se ca
n be
fata
l. Th
e risk
is h
ighe
r if y
ouus
e mor
e tha
n di
rect
ed o
r for
long
er th
an d
irect
ed.
Do n
ot u
seO
if yo
u ha
ve ev
er h
ad an
a ler
gic r
eact
ion
to an
y oth
er p
ain re
lieve
r fev
er re
duce
r O
righ
t bef
ore o
r a te
r hea
rt su
rger
yAs
k a d
octo
r bef
ore
use
ifO
stom
ach
blee
ding
war
ning
appl
ies to
you
O yo
u ha
ve a
hist
ory o
f sto
mac
h pr
oblem
s, su
ch as
hea
rtbur
nO
you
have
hig
h bl
ood
pres
sure
, hea
rt di
seas
e, liv
er ci
rrhos
is, ki
dney
dise
ase,
asth
ma,
or h
ad a
stro
keO
you
are t
akin
g a d
iure
ticO
you
have
pro
blem
s or s
erio
us si
de ef
fect
s fro
m ta
king
pain
relie
vers
or f
ever
redu
cers
Ask a
doc
tor o
r pha
rmac
ist b
efor
e us
e f y
ou a
reO
und
er a
doct
or's
care
for a
ny se
rious
cond
ition
O ta
king
aspi
rin fo
r hea
rt at
tack
or s
troke
, bec
ause
nap
roxe
n m
ay d
ecre
ase t
his
bene
fit o
f asp
irin
O ta
king
any o
ther
dru
g
Whe
n us
ing
this
pro
duct
O ta
ke w
ith fo
od o
r milk
if st
omac
h up
set o
ccur
s
Do not use if printed safety seal under cap istorn or missing.
recudeRreveF/reveileRniaP
muidoSnexorpaNgm022,seluspaC
)DIASN(
Compare to the active ingredient of ALEVE ® Liquid Gels***
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg (NSAID)
Strength to last 12 hours
Lot N
o.:
Exp.
Date
:
120 CAPSULES
Actual Size
NDC 69452 179 22
Compare to the active ingredient of ALEVE ® Liquid Gels***
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg (NSAID)
Strength to last 12 hours 120 CAPSULES
Actual Size
NDC 69452 179 22
R022
0L0
0000
00
Man
ufac
ture
d fo
r:BI
ON
PHAR
MA
600
Alex
ande
r Roa
d,Pr
ince
ton,
NJ
0854
0
***T
his
prod
uct i
s no
t man
ufac
ture
d or
dist
ribut
ed b
y th
e ow
ners
of A
LEVE
® L
iqui
d Ge
s.
Stop
use
and
ask
a d
octo
r if
O yo
u ex
perie
nce a
ny o
f the
fo lo
wing
sign
s of s
tom
ach
blee
ding
:O
feel
fain
t O
vom
it bl
ood O
hav
e blo
ody o
r blac
k sto
ols
O h
ave s
tom
ach
pain
that
doe
s not
get
bet
ter
O yo
u ha
ve sy
mpt
oms o
f hea
rt pr
oblem
s or s
troke
:O
ches
t pain
O
trou
ble b
reat
hing
O
wea
knes
s in
one p
art o
r sid
e of b
ody
O sl
urre
d sp
eech
O
leg
swell
ing
O p
ain g
ets w
orse
or l
asts
mor
e tha
n 0
days
O fe
ver g
ets w
orse
or l
asts
mor
e tha
n 3
days
O re
dnes
s or s
wellin
g is
pres
ent i
n th
e pain
ful a
rea
O an
y new
sym
ptom
s app
ear
O yo
u ha
ve d
ifficu
lty sw
a low
ing
O it
feels
like t
he ca
psul
e is s
tuck
in yo
ur th
roat
Drug
Fac
ts (c
ont n
ued)
If pr
egna
nt o
r bre
ast-f
eedi
ng, a
sk a
healt
h pr
ofes
s ona
l bef
ore u
se. I
t is e
spec
ially
impo
rtant
not
to u
se n
apro
xen
sodi
um d
urin
g th
e las
t 3 m
onth
s of p
regn
ancy
unles
s def
inite
ly di
rect
ed to
do
so b
y a d
octo
r bec
ause
it m
ay ca
use p
robl
ems i
nth
e unb
orn
child
or c
ompl
icatio
ns d
urin
g de
liver
y.Ke
ep o
ut o
f rea
ch o
f chi
ldre
n. In
case
of o
verd
ose,
get m
edica
l help
or c
onta
ct a
Poiso
n Co
ntro
l Cen
ter r
ight
away
.
Dire
ctio
nsO
do
not t
ake
mor
e th
an d
irect
edO
the
smal
lest
effe
c iv
e do
se sh
ould
be
used
O
drin
k a fu
ll glas
s of w
ater
with
each
dos
eO
if ta
ken
with
food
, thi
s pro
duct
may
take
long
er to
wor
k
Othe
r inf
orm
atio
nO
eac
h ca
psul
e co
ntai
ns: s
odiu
m 2
0 m
gO
stor
e at 2
0-25
°C (6
8-77
°F) a
void
hig
h hu
mid
ity an
d ex
cess
ive h
eat a
bove
40°C
(104
°F).
O P
rote
ct fr
om lig
ht.
O re
ad a
l dire
ctio
ns an
d wa
rnin
gs b
efor
e use
. Kee
p ca
rton.
Inac
tive
ingr
edie
nts
FD&C
blu
e #1,
gela
tin, g
lycer
in, l
actic
acid
, man
nito
l, ph
arm
aceu
tical
ink,
polye
thyle
ne g
lycol
, pov
idon
e, pr
opyle
ne g
lycol
, pur
ified
wat
er, s
orbi
tan,
sorb
itol
O ta
ke 1
caps
ule e
very
8 to
2
hour
s wh
le sy
mpt
oms l
ast
O fo
r the
firs
t dos
e you
may
take
2 ca
psul
es w
ithin
the f
irst h
our
O d
o no
t exc
eed
2 ca
psul
es in
any 8
- to
2-ho
ur p
erio
dO
do
not e
xcee
d 3
caps
ules
in a
24-h
our p
erio
d
adul
ts an
dch
ildre
n12
year
s and
olde
r:
child
ren
unde
r12
year
s: O
ask
a do
ctor
Ques
tions
or c
omm
ents
? 1-
888-
235-
2466
(Mon
- Fri
9AM
- 5P
M ES
T)
BIO
NPH
ARM
AL
ab
eli
ng
Fo
rma
t In
form
ati
on
:
Fo
nts
: Hel
vetic
a Co
nden
sed
Bold
, Hel
vetic
a Co
nden
sed,
H
elve
tica
Cond
ense
d Bo
ld O
bliq
ue
Dru
g F
ac
ts:
8pt
He
ad
er:
7pt
S
ub
he
ad
er:
6p
t B
od
y T
ex
t:
6pt
Dru
g F
ac
ts (c
ontin
ued)
: 7p
t
Hor
izon
tal S
cale
: 100
%
Aver
age
Kern
ing:
0%
Le
ad
ing
: 7.
2pt
Bu
lle
ts:
5pt
B
arl
ine
s:
.6pt
H
air
lin
es:
.2
pt
Reference ID: 4601010
160 CAPSULES
Actual Size
160 CAPSULES
Actual Size
Drug
Fac
tsAc
tive
ingr
edie
nt (i
n ea
ch ca
psul
e)
Purp
oses
Na
prox
en so
dium
220
mg
(nap
roxe
n 20
0 m
g) (N
SAID
)*...
... .. .
.. ... .
.. ... .
.. ... .
.. ... .
.. ..P
ain re
lieve
r fev
er re
duce
r *n
onste
roida
l ant
i-inf
lamm
atory
dru
g
Uses
O te
mpo
raril
y reli
eves
min
or ac
hes a
nd p
ains d
ue to
:O
min
or p
ain o
f arth
ritis O
mus
cular
ache
s O
bac
kach
e O
men
stru
al cr
amps
O
hea
dach
e O
toot
hach
e O
the c
omm
on co
ldO
tem
pora
rily r
educ
es fe
ver
War
ning
sAl
lerg
y ale
rt: N
apro
xen
sodi
um m
ay ca
use a
seve
re al
lergi
c rea
ctio
n, es
pecia
lly in
peop
le a l
ergi
c to
aspi
rin. S
ympt
oms m
ay in
clude
: O
hive
s O
facia
l swe
lling O
asth
ma (
whee
zing)
O s
hock
O
skin
redd
enin
g O
rash
O
blis
ters
If an
aller
gic r
eact
ion
occu
rs, s
top
use a
nd se
ek m
edica
l help
righ
t awa
y.St
omac
h bl
eedi
ng w
arni
ng: T
his p
rodu
ct co
ntain
s an
NSA
D, w
hich
may
caus
e se
vere
stom
ach
blee
ding
. The
chan
ce is
hig
her i
f you
:O
are a
ge 6
0 or
old
erO
hav
e had
stom
ach
ulce
rs o
r blee
ding
pro
blem
sO
take
a bl
ood
thin
ning
(ant
icoag
ulan
t) or
ster
oid
drug
O ta
ke o
ther
dru
gs co
ntain
ing
pres
crip
tion
or n
onpr
escr
iptio
n NS
AIDs
(asp
irin,
ibup
rofe
n, n
apro
xen,
or o
ther
s)O
hav
e 3 o
r mor
e alco
holic
drin
ks ev
ery d
ay w
hile
usin
g th
is pr
oduc
tO
take
mor
e or f
or a
long
er ti
me t
han
dire
cted
Hear
t a ta
ck a
nd st
roke
war
ning
: NSA
IDs,
exce
pt as
pirin
, inc
reas
e the
risk
of
hear
t atta
ck, h
eart
failu
re, a
nd st
roke
. The
se ca
n be
fata
l. Th
e risk
is h
ighe
r if y
ouus
e mor
e tha
n di
rect
ed o
r for
long
er th
an d
irect
ed.
Do n
ot u
seO
if yo
u ha
ve ev
er h
ad an
a ler
gic r
eact
ion
to an
y oth
er p
ain re
lieve
r fev
er re
duce
r O
righ
t bef
ore o
r a te
r hea
rt su
rger
yAs
k a d
octo
r bef
ore
use
ifO
stom
ach
blee
ding
war
ning
appl
ies to
you
O yo
u ha
ve a
hist
ory o
f sto
mac
h pr
oblem
s, su
ch as
hea
rtbur
nO
you
have
hig
h bl
ood
pres
sure
, hea
rt di
seas
e, liv
er ci
rrhos
is, ki
dney
dise
ase,
asth
ma,
or h
ad a
stro
keO
you
are t
akin
g a d
iure
ticO
you
have
pro
blem
s or s
erio
us si
de ef
fect
s fro
m ta
king
pain
relie
vers
or f
ever
redu
cers
Ask a
doc
tor o
r pha
rmac
ist b
efor
e us
e f y
ou a
reO
und
er a
doct
or's
care
for a
ny se
rious
cond
ition
O ta
king
aspi
rin fo
r hea
rt at
tack
or s
troke
, bec
ause
nap
roxe
n m
ay d
ecre
ase t
his
bene
fit o
f asp
irin
O ta
king
any o
ther
dru
gW
hen
usin
g th
is p
rodu
ctO
take
with
food
or m
ilk if
stom
ach
upse
t occ
urs
Do not use if printed safety seal under cap istorn or missing.
recudeRreveF/reveileRniaP
muidoSnexorpaNgm022,seluspaC
)DIASN(Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg (NSAID)
Strength to last 12 hours
Lot N
o.:
Exp.
Date
:
160 CAPSULES
Actual Size
NDC 69452 179 79
Compare to the active ingredient of ALEVE ® Liquid Gels***
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg (NSAID)
Strength to last 12 hours 160 CAPSULES
Actual Size
NDC 69452 179 79
R022
0L0
0000
00
Man
ufac
ture
d fo
r:BI
ON
PHAR
MA
600
Alex
ande
r Roa
d,Pr
ince
ton,
NJ
0854
0
Stop
use
and
ask
a d
octo
r if
O yo
u ex
perie
nce a
ny o
f the
fo lo
wing
sign
s of s
tom
ach
blee
ding
:O
feel
fain
t O
vom
it bl
ood O
hav
e blo
ody o
r blac
k sto
ols
O h
ave s
tom
ach
pain
that
doe
s not
get
bet
ter
O yo
u ha
ve sy
mpt
oms o
f hea
rt pr
oblem
s or s
troke
:O
ches
t pain
O
trou
ble b
reat
hing
O
wea
knes
s in
one p
art o
r sid
e of b
ody
O sl
urre
d sp
eech
O
leg
swell
ing
O p
ain g
ets w
orse
or l
asts
mor
e tha
n 0
days
O fe
ver g
ets w
orse
or l
asts
mor
e tha
n 3
days
O re
dnes
s or s
wellin
g is
pres
ent i
n th
e pain
ful a
rea
O an
y new
sym
ptom
s app
ear
O yo
u ha
ve d
ifficu
lty sw
a low
ing
O it
feels
like t
he ca
psul
e is s
tuck
in yo
ur th
roat
Drug
Fac
ts (c
ont n
ued)
If pr
egna
nt o
r bre
ast-f
eedi
ng, a
sk a
healt
h pr
ofes
s ona
l bef
ore u
se. I
t is e
spec
ially
impo
rtant
not
to u
se n
apro
xen
sodi
um d
urin
g th
e las
t 3 m
onth
s of p
regn
ancy
unles
s def
inite
ly di
rect
ed to
do
so b
y a d
octo
r bec
ause
it m
ay ca
use p
robl
ems i
nth
e unb
orn
child
or c
ompl
icatio
ns d
urin
g de
liver
y.Ke
ep o
ut o
f rea
ch o
f chi
ldre
n. In
case
of o
verd
ose,
get m
edica
l help
or c
onta
ct a
Poiso
n Co
ntro
l Cen
ter r
ight
away
.
Dire
ctio
nsO
do
not t
ake
mor
e th
an d
irect
edO
the
smal
lest
effe
c iv
e do
se sh
ould
be
used
O
drin
k a fu
ll glas
s of w
ater
with
each
dos
eO
if ta
ken
with
food
, thi
s pro
duct
may
take
long
er to
wor
k
Othe
r inf
orm
atio
nO
eac
h ca
psul
e co
ntai
ns: s
odiu
m 2
0 m
gO
stor
e at 2
0-25
°C (6
8-77
°F) a
void
hig
h hu
mid
ity an
d ex
cess
ive h
eat a
bove
40°C
(104
°F).
O P
rote
ct fr
om lig
ht.
O re
ad a
l dire
ctio
ns an
d wa
rnin
gs b
efor
e use
. Kee
p ca
rton.
Inac
tive
ingr
edie
nts
FD&C
blu
e #1,
gela
tin, g
lycer
in, l
actic
acid
, man
nito
l, ph
arm
aceu
tical
ink,
polye
thyle
ne g
lycol
, pov
idon
e, pr
opyle
ne g
lycol
, pur
ified
wat
er, s
orbi
tan,
sorb
itol
O ta
ke 1
caps
ule e
very
8 to
2
hour
s wh
le sy
mpt
oms l
ast
O fo
r the
firs
t dos
e you
may
take
2 ca
psul
es w
ithin
the f
irst h
our
O d
o no
t exc
eed
2 ca
psul
es in
any 8
- to
2-ho
ur p
erio
dO
do
not e
xcee
d 3
caps
ules
in a
24-h
our p
erio
d
adul
ts an
dch
ildre
n12
year
s and
olde
r:
child
ren
unde
r12
year
s: O
ask
a do
ctor
Ques
tions
or c
omm
ents
? 1-
888-
235-
2466
(Mon
- Fri
9AM
- 5P
M ES
T)
BIO
NPH
ARM
AL
ab
eli
ng
Fo
rma
t In
form
ati
on
:
Fo
nts
: Hel
vetic
a Co
nden
sed
Bold
, Hel
vetic
a Co
nden
sed,
H
elve
tica
Cond
ense
d Bo
ld O
bliq
ue
Dru
g F
ac
ts:
8pt
He
ad
er:
7pt
S
ub
he
ad
er:
6p
t B
od
y T
ex
t:
6pt
Dru
g F
ac
ts (c
ontin
ued)
: 7p
t
Hor
izon
tal S
cale
: 100
%
Aver
age
Kern
ing:
0%
Le
ad
ing
: 7.
2pt
Bu
lle
ts:
5pt
B
arl
ine
s:
.6pt
H
air
lin
es:
.2
pt
Reference ID: 4601010
160 CAPSULES
Actual Size
160 CAPSULES
Actual Size
Drug
Fac
tsAc
tive
ingr
edie
nt (i
n ea
ch ca
psul
e)
Purp
oses
Na
prox
en so
dium
220
mg
(nap
roxe
n 20
0 m
g) (N
SAID
)*...
... .. .
.. ... .
.. ... .
.. ... .
.. ... .
.. ..P
ain re
lieve
r fev
er re
duce
r *n
onste
roida
l ant
i-inf
lamm
atory
dru
g
Uses
O te
mpo
raril
y reli
eves
min
or ac
hes a
nd p
ains d
ue to
:O
min
or p
ain o
f arth
ritis O
mus
cular
ache
s O
bac
kach
e O
men
stru
al cr
amps
O
hea
dach
e O
toot
hach
e O
the c
omm
on co
ldO
tem
pora
rily r
educ
es fe
ver
War
ning
sAl
lerg
y ale
rt: N
apro
xen
sodi
um m
ay ca
use a
seve
re al
lergi
c rea
ctio
n, es
pecia
lly in
peop
le a l
ergi
c to
aspi
rin. S
ympt
oms m
ay in
clude
: O
hive
s O
facia
l swe
lling O
asth
ma (
whee
zing)
O s
hock
O
skin
redd
enin
g O
rash
O
blis
ters
If an
aller
gic r
eact
ion
occu
rs, s
top
use a
nd se
ek m
edica
l help
righ
t awa
y.St
omac
h bl
eedi
ng w
arni
ng: T
his p
rodu
ct co
ntain
s an
NSA
D, w
hich
may
caus
e se
vere
stom
ach
blee
ding
. The
chan
ce is
hig
her i
f you
:O
are a
ge 6
0 or
old
erO
hav
e had
stom
ach
ulce
rs o
r blee
ding
pro
blem
sO
take
a bl
ood
thin
ning
(ant
icoag
ulan
t) or
ster
oid
drug
O ta
ke o
ther
dru
gs co
ntain
ing
pres
crip
tion
or n
onpr
escr
iptio
n NS
AIDs
(asp
irin,
ibup
rofe
n, n
apro
xen,
or o
ther
s)O
hav
e 3 o
r mor
e alco
holic
drin
ks ev
ery d
ay w
hile
usin
g th
is pr
oduc
tO
take
mor
e or f
or a
long
er ti
me t
han
dire
cted
Hear
t a ta
ck a
nd st
roke
war
ning
: NSA
IDs,
exce
pt as
pirin
, inc
reas
e the
risk
of
hear
t atta
ck, h
eart
failu
re, a
nd st
roke
. The
se ca
n be
fata
l. Th
e risk
is h
ighe
r if y
ouus
e mor
e tha
n di
rect
ed o
r for
long
er th
an d
irect
ed.
Do n
ot u
seO
if yo
u ha
ve ev
er h
ad an
a ler
gic r
eact
ion
to an
y oth
er p
ain re
lieve
r fev
er re
duce
r O
righ
t bef
ore o
r a te
r hea
rt su
rger
yAs
k a d
octo
r bef
ore
use
ifO
stom
ach
blee
ding
war
ning
appl
ies to
you
O yo
u ha
ve a
hist
ory o
f sto
mac
h pr
oblem
s, su
ch as
hea
rtbur
nO
you
have
hig
h bl
ood
pres
sure
, hea
rt di
seas
e, liv
er ci
rrhos
is, ki
dney
dise
ase,
asth
ma,
or h
ad a
stro
keO
you
are t
akin
g a d
iure
ticO
you
have
pro
blem
s or s
erio
us si
de ef
fect
s fro
m ta
king
pain
relie
vers
or f
ever
redu
cers
Ask a
doc
tor o
r pha
rmac
ist b
efor
e us
e f y
ou a
reO
und
er a
doct
or's
care
for a
ny se
rious
cond
ition
O ta
king
aspi
rin fo
r hea
rt at
tack
or s
troke
, bec
ause
nap
roxe
n m
ay d
ecre
ase t
his
bene
fit o
f asp
irin
O ta
king
any o
ther
dru
g
Whe
n us
ing
this
pro
duct
O ta
ke w
ith fo
od o
r milk
if st
omac
h up
set o
ccur
s
Do not use if printed safety seal under cap istorn or missing.
recudeRreveF/reveileRniaP
muidoSnexorpaNgm022,seluspaC
)DIASN(
Compare to the active ingredient of ALEVE ® Liquid Gels***
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg (NSAID)
Strength to last 12 hours
Lot N
o.:
Exp.
Date
:
160 CAPSULES
Actual Size
NDC 69452 179 79
Compare to the active ingredient of ALEVE ® Liquid Gels***
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg (NSAID)
Strength to last 12 hours 160 CAPSULES
Actual Size
NDC 69452 179 79
R022
0L0
0000
00
Man
ufac
ture
d fo
r:BI
ON
PHAR
MA
600
Alex
ande
r Roa
d,Pr
ince
ton,
NJ
0854
0
***T
his
prod
uct
s no
t man
ufac
ture
d or
dist
ribut
ed b
y th
e ow
ners
of A
LEVE
® L
qui
d Ge
s.
Stop
use
and
ask
a d
octo
r if
O yo
u ex
perie
nce a
ny o
f the
fo lo
wing
sign
s of s
tom
ach
blee
ding
:O
feel
fain
t O
vom
it bl
ood O
hav
e blo
ody o
r blac
k sto
ols
O h
ave s
tom
ach
pain
that
doe
s not
get
bet
ter
O yo
u ha
ve sy
mpt
oms o
f hea
rt pr
oblem
s or s
troke
:O
ches
t pain
O
trou
ble b
reat
hing
O
wea
knes
s in
one p
art o
r sid
e of b
ody
O sl
urre
d sp
eech
O
leg
swell
ing
O p
ain g
ets w
orse
or l
asts
mor
e tha
n 0
days
O fe
ver g
ets w
orse
or l
asts
mor
e tha
n 3
days
O re
dnes
s or s
wellin
g is
pres
ent i
n th
e pain
ful a
rea
O an
y new
sym
ptom
s app
ear
O yo
u ha
ve d
ifficu
lty sw
a low
ing
O it
feels
like t
he ca
psul
e is s
tuck
in yo
ur th
roat
Drug
Fac
ts (c
ont n
ued)
If pr
egna
nt o
r bre
ast-f
eedi
ng, a
sk a
healt
h pr
ofes
s ona
l bef
ore u
se. I
t is e
spec
ially
impo
rtant
not
to u
se n
apro
xen
sodi
um d
urin
g th
e las
t 3 m
onth
s of p
regn
ancy
unles
s def
inite
ly di
rect
ed to
do
so b
y a d
octo
r bec
ause
it m
ay ca
use p
robl
ems i
nth
e unb
orn
child
or c
ompl
icatio
ns d
urin
g de
liver
y.Ke
ep o
ut o
f rea
ch o
f chi
ldre
n. In
case
of o
verd
ose,
get m
edica
l help
or c
onta
ct a
Poiso
n Co
ntro
l Cen
ter r
ight
away
.
Dire
ctio
nsO
do
not t
ake
mor
e th
an d
irect
edO
the
smal
lest
effe
c iv
e do
se sh
ould
be
used
O
drin
k a fu
ll glas
s of w
ater
with
each
dos
eO
if ta
ken
with
food
, thi
s pro
duct
may
take
long
er to
wor
k
Othe
r inf
orm
atio
nO
eac
h ca
psul
e co
ntai
ns: s
odiu
m 2
0 m
gO
stor
e at 2
0-25
°C (6
8-77
°F) a
void
hig
h hu
mid
ity an
d ex
cess
ive h
eat a
bove
40°C
(104
°F).
O P
rote
ct fr
om lig
ht.
O re
ad a
l dire
ctio
ns an
d wa
rnin
gs b
efor
e use
. Kee
p ca
rton.
Inac
tive
ingr
edie
nts
FD&C
blu
e #1,
gela
tin, g
lycer
in, l
actic
acid
, man
nito
l, ph
arm
aceu
tical
ink,
polye
thyle
ne g
lycol
, pov
idon
e, pr
opyle
ne g
lycol
, pur
ified
wat
er, s
orbi
tan,
sorb
itol
O ta
ke 1
caps
ule e
very
8 to
2
hour
s wh
le sy
mpt
oms l
ast
O fo
r the
firs
t dos
e you
may
take
2 ca
psul
es w
ithin
the f
irst h
our
O d
o no
t exc
eed
2 ca
psul
es in
any 8
- to
2-ho
ur p
erio
dO
do
not e
xcee
d 3
caps
ules
in a
24-h
our p
erio
d
adul
ts an
dch
ildre
n12
year
s and
olde
r:
child
ren
unde
r12
year
s: O
ask
a do
ctor
Ques
tions
or c
omm
ents
? 1-
888-
235-
2466
(Mon
- Fri
9AM
- 5P
M ES
T)
BIO
NPH
ARM
AL
ab
eli
ng
Fo
rma
t In
form
ati
on
:
Fo
nts
: Hel
vetic
a Co
nden
sed
Bold
, Hel
vetic
a Co
nden
sed,
H
elve
tica
Cond
ense
d Bo
ld O
bliq
ue
Dru
g F
ac
ts:
8pt
He
ad
er:
7pt
S
ub
he
ad
er:
6p
t B
od
y T
ex
t:
6pt
Dru
g F
ac
ts (c
ontin
ued)
: 7p
t
Hor
izon
tal S
cale
: 100
%
Aver
age
Kern
ing:
0%
Le
ad
ing
: 7.
2pt
Bu
lle
ts:
5pt
B
arl
ine
s:
.6pt
H
air
lin
es:
.2
pt
Reference ID: 4601010
t
s ea s
RR
up upp u C u8 C u s
tt
0
h
u sa u0 a ua ssa u0 a u s
lt
sup up ss
o
RR
g
TTT
Pa n R i ve /Fev r Reduc r
Naproxen Sodium Cap ules, 220 mg (NSA D)
Stre gth to l st 2 ho rs
0 C160 CA SUL
Pa n Rel ev r Fe er R du er
Naproxen Sodium Capsules, 220 mg (NSAID)
St ng h to la t 12 h urs
80 APSU ES
Pain R lie e F v r R d cer
Nap ox n Sodi m C psules, 2 0 mg (NSAI )
St e g h o la t 12 h rs
60 AP UL
Pain R i v r F v r R d c r
N pro en Sodium Capsules, 20 mg (NSA D)
S r n th o la t 2 h u s
16 CAP ES
N
Pa
Ca
St
6
P
NC
St
16
Pa r
80 a80 a s esa s esa s es6 ES
St thSt thSt thth
i v r F v d c r
N
S r n th t u s
8 C pC8 C uC8 C p u8 C p u8 pp uuuuu ssss C U ES
P
St
th lth lthth t
R d
diI )
rs
0 a00 u0 a u0 a u s0 s
th l
r R
di0
h
th ll
e F v rC 0
St e g h o la
UL S
th
Pa
NaproxeCa
Str
6
e r
en Sodium
l
0 C p u0 C p0 C0 C up u sL S
ve
xees
l
UL
Pa i v
xeCap u
tre g
60 CA
l
P
NC
St
6
P
NC
St
6
s
T
2 PACK 2 x 80 CT
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg (NSAID)
Strength to last 12 hours
2 Bottles x 80 Capsules Each160 CAPSULES
Do not use if printed safety seal under cap is torn or missing.
Manufactured for: Bionpharma Inc. 600 Alexander Road, Princeton, NJ 08540
2 PACK 2 x 80 CT
2 PACK 2 x 80 CT
2 PACK 2 x 80 CT
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg (NSAID)
Strength to last 12 hours
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg(NSAID)
Strength o last 12 hours
Strength to last 12 hours
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg(NSAID)
Lot No.:
Exp. Date: LO
T &
EX
Pp u sSa s es6
0 a u sS8 C p u sU
R0220 L0000000
BIONPHARMA
Labeling Format Informat on:
Fonts: Helvetica Condensed Bold Helvetica Condensed Helvetica Condensed Bold Obl que
Drug Facts: 10pt Header: 8pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): 9pt
Horizontal Scale: 100% Average Kerning: 0%
Leading: 6 5pt Bullets: 5pt Barlines: 2 5pt Hairlines: 5pt
Naproxen Sodium
n Rel ev Fe er R du er
Naproxen Sodium Capsules, 220 mg (NSAID)
ng h to la t 12 h urs
808080APSU
Pain R r R
pro en Sodium Capsules, 20 mg (NSA D)
o la 2 h
16 AP
P
St cer
m mg (NSA
Pain R lie
Nap ox n Sod psules, 2
t 12 h
60 AP
en SodiumNaproxe
/Fev r Reduc es, 220 mg (NSA D)
st 2 ho rs
0 C
n R
Napro le
th to
SU
cer (NSAID)SA
es Stre 2 hx 80 Capsules Each
St 12
80
D)
0 CTT
Drug Facts Active ingredient (in each capsule) Purposes Naproxen sodium 220 mg (naproxen 200 mg) (NSA D)*. .. .. . .. .. Pain reliever fever reducer *nonsteroidal anti-inflammatory d ug
Drug Facts (con inued)
S op use and ask a doctor if O you expe ience any of the fol owing signs of stomach b eeding: O feel faint O vomit blood O have bloody or black stools O have stomach pain that does not get better O you have symptoms of heart p oblems or stroke: O chest pain O troub e breathing O weakness in one part or side
f body O s u red speech O leg swe ling O pain gets worse or lasts more than 0 days O fever gets worse or l sts more than 3 days O redness or swel ing is p esent in the painful a ea O any new symptoms appear O you have difficu ty swa lowing O it feels ike the capsu e is stuck in your throat If pregnant or breast feeding ask a health professional before use. It is especially important not to use n proxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unbo n child or comp ications du ing de ivery. Keep out of reach of children In case of overdose, get medical he p or contact a Poison Control Center right away.
When using this product O take with food or milk if stomach upset occurs
Uses O temporarily relieves minor aches and pains due to: O minor pain of arthritis O muscular aches O backache O menstrual cramps O headache O toothache O the common cold O temporarily reduces fever
WarningsAl ergy a e t Naproxen sodium may cause a severe a lergic reaction, especially in peop e al ergic to aspirin Symptoms may inc ude: O hives O facial swe ling O asthma (wheezing) O shock skin reddening O rash O blisters f an al ergic reaction occurs, stop use and seek medical help
right away. Stomach b eeding warn ng This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or o der O have had stomach u cers or bleeding p oblems O take a blood thinning ( nticoagula t) or steroid drug O take other drugs containing prescription or nonprescription
NSA Ds (aspirin, ibuprofen, naproxen, or thers) O have 3 or more alcoho ic drinks every day whi e using this product O take more or for a longer time than directed Heart at ack and s roke warning NSA Ds, except aspirin, increase the risk f hea t a tack, heart failure, and stroke. These can be fatal. The risk is higher if you use mo e than di ected or for longer than directed. Do not use O if you have ever had an allergic reaction to any other pain
reliever fever reducer O right before or a ter heart surgery Ask a doctor before use if O stomach b eeding warning app ies to you O you have a history of stomach problems, such s hea tburn O you have high blood pressure, heart disease, liver cirrhosis,
kidney dise se, asthma, or had a stroke O you are taking a diuretic O you have prob ems or serious side effects from taking pain
re ievers or fever reducers Ask a doctor or pharmacist before use if you are O under a doctor's care for ny se ious condition O taking aspirin for heart attack or troke, because naproxen
may decrease this benefit of aspirin O taking any other d ug
Directions O do not ake more than directed O the smal est effective dose shou d be used O drink a full glass of water with each dose O if taken with food, this product may take longer to work ad ts and children 2 years
and o der:
O take 1 capsule every 8 to 12 hours whi e symptoms last
O for the first dose you may take 2 capsules within the first hour
O do not exceed 2 capsules in any 8 to 12-hour period
O do not exceed 3 capsules in a 24 hour period children under 2 years:
O ask a doctor
Other information O each capsu e contains sodium 20 mg O store at 20 25� Ġ������# =RKE@DECD humidity and excessive
heat abo e 40� Ġ ���# . O Protect f om light. O ead a l directions and warnings before use. Keep carton.
Inactive ingredients #!�C blue #1, gelat n, glycerin, lact c acid, mannitol, pharm ceutical ink, polyethylene glycol, povidone, p opylene glycol, purified water, sorbitan, so bitol
Questions or comments? 1 888 235 2466 Ġ*KJ�#ri 9AM – 5PM EST)
Reference ID: 4601010 Reference ID: 39322
t
s ea s
RR
up upp u C u8 C u s
tt
0
h
u sa u0 a ua ssa u0 a u s
lt
sup up ss
o
RR
g
TTT
Pa n R i ve /Fev r Reduc r
Naproxen Sodium Cap ules, 220 mg (NSA D)
Stre gth to l st 2 ho rs
0 C160 CA SUL
Pa n Rel ev r Fe er R du er
Naproxen Sodium Capsules, 220 mg (NSAID)
St ng h to la t 12 h urs
80 APSU ES
Pain R lie e F v r R d cer
Nap ox n Sodi m C psules, 2 0 mg (NSAI )
St e g h o la t 12 h rs
60 AP UL
Pain R i v r F v r R d c r
N pro en Sodium Capsules, 20 mg (NSA D)
S r n th o la t 2 h u s
16 CAP ES
N
Pa
Ca
St
6
P
NC
St
16
Pa r
80 a80 a s esa s esa s es6 ES
St thSt thSt thth
i v r F v d c r
N
S r n th t u s
8 C pC8 C uC8 C p u8 C p u8 pp uuuuu ssss C U ES
P
St
th lth lthth t
R d
diI )
rs
0 a00 u0 a u0 a u s0 s
th l
r R
di0
h
th ll
e F v rC 0
St e g h o la
UL S
th
Pa
NaproxeCa
Str
6
e r
en Sodium
l
0 C p u0 C p0 C0 C up u sL S
ve
xees
l
UL
Pa i v
xeCap u
tre g
60 CA
l
P
NC
St
6
P
NC
St
6
s
T
f .
2 PACK 2 x 80 CT
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg (NSAID)
Strength to last 12 hours
2 Bottles x 80 Capsules Each160 CAPSULES
Do not use if printed safety seal under cap is torn or missing.
Manufactured for: Bionpharma Inc. 600 Alexander Road, Princeton, NJ 08540
2 PACK 2 x 80 CT
2 PACK 2 x 80 CT
2 PACK 2 x 80 CT
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg (NSAID)
Strength to last 12 hours
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg(NSAID)
Strength o last 12 hours
Strength to last 12 hours
Pain Reliever/Fever Reducer
Naproxen SodiumCapsules, 220 mg(NSAID)
Lot No.:
Exp. Date: LO
T &
EX
Pp u sSa s es6
0 a u sS8 C p u sU
R0220 L0000000
BIONPHARMA
Labeling Format Informat on:
Fonts: Helvetica Condensed Bold Helvetica Condensed Helvetica Condensed Bold Obl que
Drug Facts: 10pt Header: 8pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): 9pt
Horizontal Scale: 100% Average Kerning: 0%
Leading: 6 5pt Bullets: 5pt Barlines: 2 5pt Hairlines: 5pt
Naproxen Sodium
n Rel ev Fe er R du er
Naproxen Sodium Capsules, 220 mg (NSAID)
ng h to la t 12 h urs
808080APSU
Pain R r R
pro en Sodium Capsules, 20 mg (NSA D)
o la 2 h
16 AP
P
St cer
m mg (NSA
Pain R lie
Nap ox n Sod psules, 2
t 12 h
60 AP
en SodiumNaproxe
/Fev r Reduc es, 220 mg (NSA D)
st 2 ho rs
0 C
n R
Napro le
th to
SU
cer (NSAID)SA
es Stre 2 hx 80 Capsules Each
St 12
80
D)
0 CTT
Compare to the active ingredient of ALEVE® Liquid Gels***
Compare to the active ingredient of ALEVE® Liquid Gels***
***This p odu t is n t m n tured or di trib ted by the owners f ALEVE Liquid Gel
Drug Facts Active ingredient (in each capsule) Purposes Naproxen sodium 220 mg (naproxen 200 mg) (NSA D)*. .. .. . .. .. Pain reliever fever reducer *nonsteroidal anti-inflammatory d ug
Drug Facts (con inued)
S op use and ask a doctor if O you expe ience any of the fol owing signs of stomach b eeding: O feel faint O vomit blood O have bloody or black stools O have stomach pain that does not get better O you have symptoms of heart p oblems or stroke: O chest pain O troub e breathing O weakness in one part or side
f body O s u red speech O leg swe ling O pain gets worse or lasts more than 0 days O fever gets worse or l sts more than 3 days O redness or swel ing is p esent in the painful a ea O any new symptoms appear O you have difficu ty swa lowing O it feels ike the capsu e is stuck in your throat If pregnant or breast feeding ask a health professional before use. It is especially important not to use n proxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unbo n child or comp ications du ing de ivery. Keep out of reach of children In case of overdose, get medical he p or contact a Poison Control Center right away.
When using this product O take with food or milk if stomach upset occurs
Uses O temporarily relieves minor aches and pains due to: O minor pain of arthritis O muscular aches O backache O menstrual cramps O headache O toothache O the common cold O temporarily reduces fever
WarningsAl ergy a e t Naproxen sodium may cause a severe a lergic reaction, especially in peop e al ergic to aspirin Symptoms may inc ude: O hives O facial swe ling O asthma (wheezing) O shock skin reddening O rash O blisters f an al ergic reaction occurs, stop use and seek medical help
right away. Stomach b eeding warn ng This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or o der O have had stomach u cers or bleeding p oblems O take a blood thinning ( nticoagula t) or steroid drug O take other drugs containing prescription or nonprescription
NSA Ds (aspirin, ibuprofen, naproxen, or thers) O have 3 or more alcoho ic drinks every day whi e using this product O take more or for a longer time than directed Heart at ack and s roke warning NSA Ds, except aspirin, increase the risk f hea t a tack, heart failure, and stroke. These can be fatal. The risk is higher if you use mo e than di ected or for longer than directed. Do not use O if you have ever had an allergic reaction to any other pain
reliever fever reducer O right before or a ter heart surgery Ask a doctor before use if O stomach b eeding warning app ies to you O you have a history of stomach problems, such s hea tburn O you have high blood pressure, heart disease, liver cirrhosis,
kidney dise se, asthma, or had a stroke O you are taking a diuretic O you have prob ems or serious side effects from taking pain
re ievers or fever reducers Ask a doctor or pharmacist before use if you are O under a doctor's care for ny se ious condition O taking aspirin for heart attack or troke, because naproxen
may decrease this benefit of aspirin O taking any other d ug
Directions O do not ake more than directed O the smal est effective dose shou d be used O drink a full glass of water with each dose O if taken with food, this product may take longer to work ad ts and children 2 years
and o der:
O take 1 capsule every 8 to 12 hours whi e symptoms last
O for the first dose you may take 2 capsules within the first hour
O do not exceed 2 capsules in any 8 to 12-hour period
O do not exceed 3 capsules in a 24 hour period children under 2 years:
O ask a doctor
Other information O each capsu e contains sodium 20 mg O store at 20 25� Ġ������# =RKE@DECD humidity and excessive
heat abo e 40� Ġ ���# . O Protect f om light. O ead a l directions and warnings before use. Keep carton.
Inactive ingredients #!�C blue #1, gelat n, glycerin, lact c acid, mannitol, pharm ceutical ink, polyethylene glycol, povidone, p opylene glycol, purified water, sorbitan, so bitol
Questions or comments? 1 888 235 2466 Ġ*KJ�#ri 9AM – 5PM EST)
Reference ID: 4601010 Reference ID: 39322
o i .rn or miss .
Imprint/NV Area Front 0.5000"
2.37
50"
6.2500"
Pain Reliever/Fever Reducer
Naproxen Sodium Capsules, 220 mg (NSAID)
Strength to last 12 hours
NDC 69425-179-79
Do not use if printed safety seal under cap istorn or missing.
1
r r m ssinging
12 hours
*nonsteroidal anti-inflammatory drug
Drug Facts Active ingredient (in each capsule) Purposes Naproxen sodium 220 mg (naproxen 200 mg) (NSA D)*...................................Pain reliever/fever reducer
Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: O hives O facial swelling O asthma (wheezing) O shock O skin reddening O rash O blisters. If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSA D, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or older O have had stomach ulcers or bleeding problems O take a blood thinning (anticoagulant) or steroid drug O take other drugs containing prescription or nonprescription NSA Ds (aspirin, ibuprofen, naproxen, or others) O have 3 or more alcoholic drinks every day while using this product O take more or for a longer time than directed Heart attack and stroke warning: NSA Ds, except aspirin, increase the risk of heart attack, heart fa lure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Uses O temporarily relieves minor aches and pains due to: O minor pain of arthritis O muscular aches O backache O menstrual cramps O headache O toothache O the common cold O temporarily reduces fever
Do not use O if you have ever had an allergic reaction to any other pain reliever/fever reducer O right before or after heart surgery
160 CAPSULES Actual Size
Man
ufac
ture
d fo
r:
B IO
N P
HAR
MA
600
Alex
ande
r Roa
d,Pr
ince
ton,
NJ
0854
0
L000
0000
R02
20
Lot/E
XP
R 0.1250"
Hinge/NV Area Back 1.0000"
2.37
50"
Drug
Fac
ts (c
ontin
ued)
Ask a
docto
r befo
re us
e if O
stom
ach b
leedin
g warn
ing ap
plies
to yo
uO
you h
ave a
histo
ry of
stom
ach p
roble
ms,
such
as he
artbu
rn O
you
have
high
bloo
d pres
sure,
heart
dise
ase,
liver
cirrh
osis,
kidn
ey di
seas
e,as
thma,
or ha
d a st
roke
O yo
u are
taking
a diu
retic O
you h
ave p
roble
ms
or se
rious
side
effec
ts fro
m ta
king p
ain re
lieve
rs or
feve
r red
ucers
Ask a
docto
r or p
harm
acist
befor
e use
if yo
u are
O un
der a
docto
r's ca
refor
any s
eriou
s con
dition
O ta
king a
spirin
for h
eart a
ttack
or st
roke,
beca
use
napr
oxen
may
decre
ase t
his be
nefit
of as
pirin O
takin
g any
othe
r dru
gW
hen
usin
g th
is pr
oduc
t O
take
with
food
or m
ilk if
stom
ach
upse
t occ
urs
Stop
use a
nd as
k a do
ctor i
fO
you e
xperi
ence
any o
f the f
ollow
ing si
gns o
f stom
ach b
leedin
g:O
feel
faint O
vom
it bloo
d O
have
bloo
dy or
blac
k stoo
lsO
have
stom
ach p
ain th
at do
es no
t get
bette
rO
you
have
sym
ptom
s of h
eart
prob
lems o
r stro
ke:
O ch
est p
ain O
troub
le br
eathi
ng O
slurre
d spe
ech
O w
eakn
ess i
n one
part
or si
de o
f bod
y O
leg sw
elling
O
pain
gets
worse
or la
sts m
ore t
han 1
0 day
sO
feve
r gets
wor
se or
lasts
mor
e tha
n 3 da
ysO
redn
ess o
r swe
lling i
s pres
ent in
the p
ainful
area
O an
y new
sym
ptom
s app
ear
O yo
u hav
e diffi
culty
swall
owing
O it
feels
like t
he ca
psule
is st
uck i
n you
r thr
oat
If pr
egna
nt or
bre
ast-f
eedin
g, as
k a he
alth p
rofes
siona
l befo
re us
e.It
is es
pecia
lly im
porta
nt no
t to u
se na
prox
en so
dium
durin
g the
last
3 mon
ths of
preg
nanc
y unle
ss de
finite
ly dir
ected
to do
so by
a do
ctor
beca
use i
t may
caus
e pro
blem
s in t
he un
born
child
or co
mpli
catio
nsdu
ring d
elive
ry.Ke
ep ou
t of r
each
of ch
ildre
n. In
case
of ov
erdos
e, ge
t med
ical h
elpor
conta
ct a P
oison
Con
trol C
enter
righ
t awa
y.
Dire
ction
s O
do no
t tak
e mor
e tha
n dire
cted O
the s
mall
est
effec
tive d
ose s
hould
be us
ed O
drink
a ful
l glas
s of w
ater w
ithea
ch do
se O
if tak
en w
ith fo
od, th
is pr
oduc
t may
take
long
er to
work
Inac
tive i
ngre
dients
FD&
C blu
e #1,
gelat
in, gl
yceri
n, lac
tic ac
id,m
annit
ol, ph
armac
eutic
al ink
, poly
ethyle
ne gl
ycol,
povid
one,
prop
ylene
glyco
l, pur
ified w
ater, s
orbit
an, s
orbit
ol
Ques
tions
or co
mm
ents?
1-88
8-23
5-24
66 (M
on - F
ri 9AM
- 5PM
EST)
adult
s and
child
ren12
years
and
older:
O ta
ke 1
caps
ule ev
ery 8
to 12
hour
s whil
e sym
ptom
s las
tO
for th
e firs
t dos
e you
may
take
2 ca
psule
s with
in the
firs
t hou
r O
do n
ot ex
ceed
2 ca
psule
s in a
ny 8-
to 12
-hou
r peri
odO
do no
t exc
eed 3
caps
ules i
n a 24
-hou
r peri
odO
ask a
docto
rch
ildren
unde
r12
years
:
Othe
r inf
orm
atio
n O
each
caps
ule co
ntains
: sod
ium 20
mg
O st
ore a
t 20-
25°C
(68-
77°F
) avo
id hig
h hum
idity
and e
xces
sive h
eat
abov
e 40°
C (10
4°F).
O Pr
otect
from
light.
O re
ad al
l dire
ction
s and
warn
ings b
efore
use.
6.2500"
BIONPHARMA
Labeling Format Information:
Fonts: Helvetica Condensed Bold, Helvetica Condensed, Helvetica Condensed Bold Oblique
Drug Facts: 8pt Header: 7pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): 7pt
Horizontal Scale: 100% Average Kerning: 0%
Leading: 6.5pt Bullets: 5pt Barlines: 7pt Hairlines: .5pt
1.95
32"
Imp
rin
t/N
V A
rea
Reference ID: 4601010
o i .rn or miss .
Imprint/NV Area Front 0.5000"
2.37
50"
6.2500"
Pain Reliever/Fever Reducer
Naproxen Sodium Capsules, 220 mg (NSAID)
Strength to last 12 hours
NDC 69425-179-79
Do not use if printed safety seal under cap istorn or missing.
1
r r m ssinging
12 hours
*nonsteroidal anti-inflammatory drug
Drug Facts Active ingredient (in each capsule) Purposes Naproxen sodium 220 mg (naproxen 200 mg) (NSA D)*...................................Pain reliever/fever reducer
Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: O hives O facial swelling O asthma (wheezing) O shock O skin reddening O rash O blisters. If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSA D, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or older O have had stomach ulcers or bleeding problems O take a blood thinning (anticoagulant) or steroid drug O take other drugs containing prescription or nonprescription NSA Ds (aspirin, ibuprofen, naproxen, or others) O have 3 or more alcoholic drinks every day while using this product O take more or for a longer time than directed Heart attack and stroke warning: NSA Ds, except aspirin, increase the risk of heart attack, heart fa lure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Uses O temporarily relieves minor aches and pains due to: O minor pain of arthritis O muscular aches O backache O menstrual cramps O headache O toothache O the common cold O temporarily reduces fever
Do not use O if you have ever had an allergic reaction to any other pain reliever/fever reducer O right before or after heart surgery
160 CAPSULES Actual Size
Compare to the active ingredient of ALEVE ® Liquid Gels***
***T
his p
rodu
ct is
not m
anuf
actu
red
or d
istrib
uted
by t
he o
wner
s of A
LEVE
® L
iquid
Gels.
Man
ufac
ture
d fo
r:
B IO
N P
HAR
MA
600
Alex
ande
r Roa
d,Pr
ince
ton,
NJ
0854
0
L000
0000
R02
20
Lot/E
XP
R 0.1250"
Hinge/NV Area Back 1.0000"
2.37
50"
Drug
Fac
ts (c
ontin
ued)
Ask a
docto
r befo
re us
e if O
stom
ach b
leedin
g warn
ing ap
plies
to yo
uO
you h
ave a
histo
ry of
stom
ach p
roble
ms,
such
as he
artbu
rn O
you
have
high
bloo
d pres
sure,
heart
dise
ase,
liver
cirrh
osis,
kidn
ey di
seas
e,as
thma,
or ha
d a st
roke
O yo
u are
taking
a diu
retic O
you h
ave p
roble
ms
or se
rious
side
effec
ts fro
m ta
king p
ain re
lieve
rs or
feve
r red
ucers
Ask a
docto
r or p
harm
acist
befor
e use
if yo
u are
O un
der a
docto
r's ca
refor
any s
eriou
s con
dition
O ta
king a
spirin
for h
eart a
ttack
or st
roke,
beca
use
napr
oxen
may
decre
ase t
his be
nefit
of as
pirin O
takin
g any
othe
r dru
gW
hen
usin
g th
is pr
oduc
t O
take
with
food
or m
ilk if
stom
ach
upse
t occ
urs
Stop
use a
nd as
k a do
ctor i
fO
you e
xperi
ence
any o
f the f
ollow
ing si
gns o
f stom
ach b
leedin
g:O
feel
faint O
vom
it bloo
d O
have
bloo
dy or
blac
k stoo
lsO
have
stom
ach p
ain th
at do
es no
t get
bette
rO
you
have
sym
ptom
s of h
eart
prob
lems o
r stro
ke:
O ch
est p
ain O
troub
le br
eathi
ng O
slurre
d spe
ech
O w
eakn
ess i
n one
part
or si
de o
f bod
y O
leg sw
elling
O
pain
gets
worse
or la
sts m
ore t
han 1
0 day
sO
feve
r gets
wor
se or
lasts
mor
e tha
n 3 da
ysO
redn
ess o
r swe
lling i
s pres
ent in
the p
ainful
area
O an
y new
sym
ptom
s app
ear
O yo
u hav
e diffi
culty
swall
owing
O it
feels
like t
he ca
psule
is st
uck i
n you
r thr
oat
If pr
egna
nt or
bre
ast-f
eedin
g, as
k a he
alth p
rofes
siona
l befo
re us
e.It
is es
pecia
lly im
porta
nt no
t to u
se na
prox
en so
dium
durin
g the
last
3 mon
ths of
preg
nanc
y unle
ss de
finite
ly dir
ected
to do
so by
a do
ctor
beca
use i
t may
caus
e pro
blem
s in t
he un
born
child
or co
mpli
catio
nsdu
ring d
elive
ry.Ke
ep ou
t of r
each
of ch
ildre
n. In
case
of ov
erdos
e, ge
t med
ical h
elpor
conta
ct a P
oison
Con
trol C
enter
righ
t awa
y.
Dire
ction
s O
do no
t tak
e mor
e tha
n dire
cted O
the s
mall
est
effec
tive d
ose s
hould
be us
ed O
drink
a ful
l glas
s of w
ater w
ithea
ch do
se O
if tak
en w
ith fo
od, th
is pr
oduc
t may
take
long
er to
work
Inac
tive i
ngre
dients
FD&
C blu
e #1,
gelat
in, gl
yceri
n, lac
tic ac
id,m
annit
ol, ph
armac
eutic
al ink
, poly
ethyle
ne gl
ycol,
povid
one,
prop
ylene
glyco
l, pur
ified w
ater, s
orbit
an, s
orbit
ol
Ques
tions
or co
mm
ents?
1-88
8-23
5-24
66 (M
on - F
ri 9AM
- 5PM
EST)
adult
s and
child
ren12
years
and
older:
O ta
ke 1
caps
ule ev
ery 8
to 12
hour
s whil
e sym
ptom
s las
tO
for th
e firs
t dos
e you
may
take
2 ca
psule
s with
in the
firs
t hou
r O
do n
ot ex
ceed
2 ca
psule
s in a
ny 8-
to 12
-hou
r peri
odO
do no
t exc
eed 3
caps
ules i
n a 24
-hou
r peri
odO
ask a
docto
rch
ildren
unde
r12
years
:
Othe
r inf
orm
atio
n O
each
caps
ule co
ntains
: sod
ium 20
mg
O st
ore a
t 20-
25°C
(68-
77°F
) avo
id hig
h hum
idity
and e
xces
sive h
eat
abov
e 40°
C (10
4°F).
O Pr
otect
from
light.
O re
ad al
l dire
ction
s and
warn
ings b
efore
use.
6.2500"
BIONPHARMA
Labeling Format Information:
Fonts: Helvetica Condensed Bold, Helvetica Condensed, Helvetica Condensed Bold Oblique
Drug Facts: 8pt Header: 7pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): 7pt
Horizontal Scale: 100% Average Kerning: 0%
Leading: 6.5pt Bullets: 5pt Barlines: 7pt Hairlines: .5pt
1.95
32"
Imp
rin
t/N
V A
rea
Reference ID: 4601010
to
**liquid-filled capsule80 capsules**
aa
**li id fill d l
**liq
uid-
fille
d ca
psul
e80
cap
sule
s**
°
l
°C sC s
-
t
**li
idfil
ld
l
Drug
Fac
tsAc
tive i
ngred
ient (i
n eac
h cap
sule)
Purpo
ses
Napr
oxen
sod u
m 22
0 mg
(nap
roxe
n 200
mg)
(NSA
ID)*
.. ... .
.. ... .
.. ... .
.. ... .
.. ... .
.. Pa n
re e
ver/f
ever
reduc
er*n
onste
ro da
ant -
nf am
mator
y dru
g
Uses
O te
mpor
ar y r
e ev
es m
nor a
ches
and p
a ns d
ue to
:O
m no
r pa n
of ar
thr t s
O
mus
cu ar
ache
s O
back
ache
O
men
strua
cram
ps
O he
adac
he
O to
othac
he
O h
e com
mon c
o dO
temp
orar
y red
uces
feve
r
War
nings
Aller
gy al
ert: N
apro
xen s
od um
may
caus
e a se
vere
a erg
c rea
ct on
, esp
ec a
y n
peop
e a
erg c
to as
p r n.
Symp
toms m
ay n
c ude
:O
h ve
s O
fac a
swe
ng O
asthm
a (wh
eez n
g) O
shoc
k O
sk n
redde
n ng
O ra
sh O
b ste
rsIf
an a
erg c
react
on oc
curs,
stop
use a
nd se
ek m
ed ca
he p
r gh
t awa
y. St
omac
h blee
ding w
arnin
g: Th
s pr
oduc
t con
ta ns
an N
SAID
, wh c
h may
caus
e se
vere
stoma
ch b
eed n
g. Th
e cha
nce
s h gh
er f y
ou:
O ar
e age
60 or
o de
rO
have
had s
tomac
h u ce
rs or
b ee
d ng p
rob e
msO
take
a b o
od th
nn ng
(ant
coag
u ant)
or st
ero d
drug
O ta
ke ot
her d
rugs
con a
n ng
pres
cr pt
on or
nonp
rescr
pt on
NSA
IDs (
asp r
n,
bupr
ofen,
napr
oxen
, or o
thers)
O ha
ve 3
or m
ore a
coho
c dr
nks e
very
day w
h e u
s ng t
h s pr
oduc
tO
take
mor
e or f
or a
onge
r t m
e tha
n d re
cted
Hear
t atta
ck an
d stro
ke w
arnin
g: NS
AIDs
, exc
ept a
sp r n
, ncre
ase t
he r
sk of
he
art at
tack,
heart
fa u
re, an
d stro
ke. T
hese
can b
e fata
. The
r sk
s h
gher
f you
us
e mor
e tha
n d re
cted o
r for
ong
er tha
n d re
cted.
Do no
t use
O f
you h
ave e
ver h
ad an
a erg
c rea
ct on
to an
y othe
r pa n
re e
ver/f
ever
reduc
erO
r ght
befor
e or a
fter h
eart
surg
ery
Ask a
docto
r befo
re us
e if
O st
omac
h b ee
d ng w
arn ng
app
es to
you
O yo
u hav
e a h
story
of sto
mach
prob
ems,
such
as he
artbu
rnO
you h
ave h
gh b
ood p
ressu
re, he
art d
seas
e, ve
r c rr
hos s
, k dn
ey d
seas
e, as
thma,
or ha
d a st
roke
O yo
u are
ak ng
a d u
ret c
O yo
u hav
e pro
b ems
or se
r ous
s de
effec
ts fro
m tak
ng pa
n re
evers
or fe
ver
reduc
ersAs
k a do
ctor o
r pha
rmac
ist be
fore u
se f
you a
reO
unde
r a do
ctor s
care
for an
y ser
ous c
ond t
onO
tak n
g asp
r n f
or he
art a
ttack
or st
roke
, bec
ause
napr
oxen
may
decr
ease
th s
be
nef t
of as
p r n
O ta
k ng a
ny ot
her d
rug
R022
0L0
0000
00
Exp.
Date
:
Lot:
LOT
& E
XP
Man
ufac
ture
d fo
r:BI
ON
PHAR
MA
600
Alex
ande
r Roa
d,Pr
ince
ton,
NJ
0854
0
***T
h s p
rodu
ct s n
ot m
anu
actu
red
or d
str b
uted
by t
he o
wner
sof
ALE
VE® L
qu d
Ge s.
ch d
ren u
nder
12 ye
ars
O ta
ke 1
caps
u e ev
ery 8
to 12
hour
s wh
e sym
ptom
s as
t O
for t
he f r
st do
se yo
u may
take
2 ca
psu e
s w th
n he
f rst
hour
O
do no
t exc
eed 2
caps
u es
n any
8- to
12-h
our p
er od
O do
not e
xcee
d 3 ca
psu e
s n a
24-h
our p
er od
adu
s and
ch d
ren12
years
and o
der:
O as
k a do
ctor
Drug
Fac
ts (c
ontin
ued)
Whe
n usin
g his
prod
uct
O ta
ke w
th fo
od or
m k
f sto
mac
h ups
et oc
curs
Stop
use a
nd as
k a do
ctor i
fO
you e
xper
ence
any o
f the f
o ow
ng s
gns o
f stom
ach b
eed n
g:O
fee
fa nt
O vo
m t b
ood O
have
b oo
dy or
b ac
k stoo
sO
have
stom
ach p
a n th
at do
es no
t get
bette
rO
you h
ave s
ympto
ms of
heart
prob
ems o
r stro
ke:
O ch
est p
a n O
trou
b e br
eath
ng O
wea
knes
s n o
ne pa
rt or
s de
of bo
dyO
s ur
red sp
eech
O e
g swe
ng
O pa
n ge
ts wo
rse or
as s
mor
e ha
n 10 d
ays
O fe
ver g
ets w
orse
or a
sts m
ore t
han 3
days
O re
dnes
s or s
we n
g s p
rese
nt n
the p
a nfu
area
O an
y new
sym
ptom
s app
ear
O yo
u hav
e d ff
cu ty
swa
ow ng
O
t fee
s ke
the c
apsu
e s s
tuck
n yo
ur th
roat
If pre
gnan
t or b
reas
t-fee
ding,
ask a
hea t
h pro
fess o
na b
efore
use.
It s e
spec
a y
mpo
rtant
not t
o use
napr
oxen
sod u
m du
r ng t
he a
st 3 m
onths
of pr
egna
ncy u
n ess
de
f n te
y d r
ected
to do
so by
a do
ctor b
ecau
se t
may
caus
e pro
b em
s n t
he un
born
ch
d or
com
p ca
t ons
dur n
g de
very.
Kee
p out
of re
ach o
f chil
dren
. In ca
se of
overd
ose,
get m
ed ca
he p
or co
ntact
a Po s
on C
ontro
Cen
ter r g
ht aw
ay.
Dire
ction
sO
do no
t take
mo
e tha
n dire
cted
O th
e sma
llest
effec
tive d
ose s
hould
be us
edO
dr nk
a fu
g as
s of w
ater w
th ea
ch do
seO
f tak
en w
th fo
od, th
s pr
oduc
t may
take
ong
er to
work
Othe
r inf
orm
atio
nO
each
caps
ule c
onta
ins:
sod u
m 20
mg
O st
ore at
20-25
°C (6
8-77°
F) av
o d h
gh hu
m d t
y and
exce
ss ve
heat
abov
e 40°
C (10
4°F)
O P
rotec
t fro
m g
ht.
O re
ad a
d re
ct on
s and
war
n ngs
befo
re us
e. Ke
ep ca
rton.
Inac
tive i
ngre
dien
tsFD
&C b
ue #1
, ge a
t n, g
ycer
n, a
ct c a
c d, m
ann t
o , ph
arm
aceu
t ca
nkpo
yeth
y ene
g yc
o , po
v don
e, pr
opy e
ne g
yco ,
pur f
ed w
ater, s
orb t
an, s
orb
Ques
tions
or co
mm
ents?
1-88
8-23
5-24
66 (M
on -
Fr 9A
M -5
PM ES
T)
***compare to the active ingredient in ALEVE® Liquid Gels
pain reliever/fever reducer
strength to last 12 hours
pain
rel
ieve
r/fe
ver
redu
cer
stre
ngth
tola
st 1
2 ho
urs
*** c
ompa
re to
the
activ
e in
gred
ient
in A
LEV
E®
Liq
uid
Gel
s
ai
**liquid-filled capsule 80 capsules**
pa Do not use if printed safety seal under cap is
torn or missing.
s
**liq
uid
fille
d ca
psul
e
C (10
4°F)
orb
o
80 c
apsu
les*
*
naproxen sodium capsules, 220 mg (NSAID)
naproxen sodium capsules, 220 mg (NSAID)
napr
oxen
sodi
umca
psul
es, 2
20 m
g(N
SAID
)
BIO
NPH
ARM
AL
ab
eli
ng
Fo
rma
t In
form
ati
on
:
Fo
nts
: Hel
vetic
a Co
nden
sed
Bold
, Hel
vetic
a Co
nden
sed,
H
elve
tica
Cond
ense
d Bo
ld O
bliq
ue
Dru
g F
ac
ts:
14pt
H
ea
de
r: 8
pt
Su
bh
ea
de
r:
6pt
Bo
dy
Te
xt:
6p
t D
rug
Fa
cts
(con
tinue
d):
N/A
Hor
izon
tal S
cale
: 94%
Av
erag
e Ke
rnin
g: 0
%
Le
ad
ing
: 6.
5pt
Bu
lle
ts:
5pt
B
arl
ine
s:
2.43
1pt
Ha
irli
ne
s:
.486
pt
Reference ID: 4601010
Lot/E
XPR0
220
L000
0000
Non
Var
nish
Are
a
120 capsules**
***compare to the active ingredientin ALEVE® Liquid Gels
Man
ufac
ture
d fo
r: BI
ON
PHAR
MA
600
Alex
ande
r Roa
d, P
rince
ton,
NJ
0854
0
Do n
ot u
se if
prin
ted
safe
ty se
al un
der c
ap is
torn
or m
issin
g.
Drug FactsActive ingredient (in each capsule) PurposesNaproxen sodium 220 mg (naproxen 200 mg) (NSAID)*..........................................Pain reliever/fever reducer*nonsteroidal anti-inflammatory drug
Uses O temporarily relieves minor aches and pains due to:O minor pain of arthritis O muscular aches O backache O menstrual crampsO headache O toothache O the common cold O temporarily reduces fever
WarningsAllergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: O hives O facial swelling O asthma (wheezing) O shock O skin reddening O rash O blisters.If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or older O have had stomach ulcers or bleeding problems O take a blood thinning (anticoagulant) or steroid drug O take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) O have 3 or more alcoholic drinks every day while using this product O take more or for a longer time than directedHeart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.Do not use O if you have ever had an allergic reaction to any other pain reliever/fever reducer O right before or after surgery **
*Thi
s pr
oduc
t is
not m
anuf
actu
red
or d
istri
bute
d by
the
owne
rs o
f ALE
VE® L
iqui
d Ge
ls.
**liquid-fill d capsule
55”
.125”.125” ccorner radiusorner radius
Front
2.375”2.375”
trength to last 12 hours
55”
121 0 capsules** **liquid-filled capsule
strength
pain reliever/fever reducer
naproxen sodiumcapsules, 220 mg(NSAID)
6.25”
Back
2.375”2.375”
Drug
Fac
ts (c
ontin
ued)
Ask a
docto
r befo
re us
e if O
stom
ach b
leedin
g warn
ing ap
plies
to yo
uO
you h
ave a
histo
ry of
stom
ach p
roble
ms,
such
as he
artbu
rn O
you h
ave
high b
lood p
ressu
re, he
art di
seas
e, liv
er cir
rhos
is, ki
dney
dise
ase,
asthm
a, or
had a
stro
ke O
you a
re tak
ing a
diuret
ic O
you h
ave p
roble
ms o
rse
rious
side
effec
ts fro
m ta
king p
ain re
lieve
rs or
feve
r red
ucers
Ask a
docto
r or p
harm
acist
befor
e use
if yo
u are
O
unde
r a do
ctor's
care
for an
y seri
ous c
ondit
ion O
takin
g asp
irin fo
r hea
rt att
ack o
r stro
ke,
beca
use n
apro
xen m
ay de
creas
e this
bene
fit of
aspir
in O
takin
g any
othe
rdr
ugW
hen u
sing t
his pr
oduc
t O
take
with
food
or m
ilk if
stom
ach u
pset
occu
rsSt
op us
e and
ask a
docto
r if
O yo
u exp
erien
ce an
y of t
he fo
llowi
ng si
gns o
f stom
ach b
leedin
g:O
feel
faint
O vo
mit b
lood
O ha
ve bl
oody
or bl
ack s
tools
O ha
ve st
omac
h pain
that
does
not g
et be
tter
O yo
u hav
e sym
ptom
s of h
eart
prob
lems o
r stro
ke:
O ch
est p
ain O
trou
ble br
eathi
ng O
wea
knes
s in o
ne pa
rt or
side
of bo
dyO
slur
red sp
eech
O
leg s
wellin
g O
pain
gets
worse
or la
sts m
ore t
han 1
0 day
s O
feve
r gets
wor
se or
lasts
mor
e tha
n 3 da
ys O
redn
ess o
r swe
lling i
s pres
ent in
the p
ainful
area
O an
y new
sym
ptom
s app
ear
O yo
u hav
e diffi
culty
swall
owing
O it
feels
like t
he ca
psule
is st
uck i
n you
r thr
oat
If pr
egna
nt or
brea
st-fee
ding,
ask a
healt
h pro
fessio
nal b
efore
use.
It is
espe
cially
impo
rtant
not t
o use
napr
oxen
sodiu
m du
ring t
he la
st 3 m
onths
ofpr
egna
ncy u
nless
defin
itely
direc
ted to
do so
by a
docto
r bec
ause
it m
ayca
use p
roble
ms i
n the
unbo
rn ch
ild or
com
plica
tions
durin
g deli
very.
Keep
out o
f rea
ch of
child
ren.
In ca
se of
overd
ose,
get m
edica
l help
orco
ntact
a Pois
on C
ontro
l Cen
ter ri
ght a
way.
Dire
ction
s O
do no
t tak
e mor
e tha
n dire
cted
O th
e sm
alles
t eff
ectiv
e dos
e sho
uld be
used
O
drink
a ful
l glas
s of w
ater w
ith ea
ch do
seO
if tak
en w
ith fo
od, th
is pr
oduc
t may
take
long
er to
work
Othe
r info
rmati
on O
each
caps
ule co
ntains
: sod
ium 20
mg
O st
ore a
t 20-
25°C
(68-
77°F
) avo
id hig
h hum
idity
and e
xces
sive h
eat a
bove
40°C
(104
°F).
O Pr
otect
from
ight.
O
read
all d
irecti
ons a
nd w
arning
s befo
reus
e. Inacti
ve in
gred
ients
FD&C
blue
#1, g
elatin
, glyc
erin,
lactic
acid,
man
nitol,
pharm
aceu
tical
ink, p
olyeth
ylene
glyc
ol, po
vidon
e, pr
opyle
ne gl
ycol,
purif
ied w
ater,
sorb
itan,
sorb
itol
Ques
tions
or co
mm
ents?
1-88
8-23
5-24
66 (M
on -
Fri 9A
M -5
PM ES
T)
adult
s and
child
ren 12
years
and
older:
O ta
ke 1
caps
ule ev
ery 8
to 12
hour
s whil
e sym
ptom
s las
tO
for t
he fir
st do
se yo
u may
take
2 ca
psule
s with
in the
first
hour
O do
not e
xcee
d 2 ca
psule
s in a
ny 8-
to 12
-hou
r peri
odO
do no
t exc
eed 3
caps
ules i
n a 24
-hou
r peri
odO
ask a
docto
rch
ildren
unde
r12
years
:
6.25”
BIONPHARMA Labeling Format Information:
Fonts: Helvetica Condensed Bold, Helvetica Condensed, Helvetica Condensed Bold Oblique
Drug Facts: 9pt Header: 8pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): N/A
Horizontal Scale: 85% Average Kerning: 0%
Leading: 6.5pt Bullets: 5pt Barlines: 2pt Hairlines: .5pt
Reference ID: 4601010
Lot/E
XPR0
220
L000
0000
Non
Var
nish
Are
a
180 capsules**
***compare to the active ingredientin ALEVE® Liquid Gels
Man
ufac
ture
d fo
r: BI
ON
PHAR
MA
600
Alex
ande
r Roa
d, P
rince
ton,
NJ
0854
0
Do n
ot u
se if
prin
ted
safe
ty se
al un
der c
ap is
torn
or m
issin
g.
Drug FactsActive ingredient (in each capsule) PurposesNaproxen sodium 220 mg (naproxen 200 mg) (NSAID)*..........................................Pain reliever/fever reducer*nonsteroidal anti-inflammatory drug
Uses O temporarily relieves minor aches and pains due to:O minor pain of arthritis O muscular aches O backache O menstrual crampsO headache O toothache O the common cold O temporarily reduces fever
WarningsAllergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: O hives O facial swelling O asthma (wheezing) O shock O skin reddening O rash O blisters.If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or older O have had stomach ulcers or bleeding problems O take a blood thinning (anticoagulant) or steroid drug O take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) O have 3 or more alcoholic drinks every day while using this product O take more or for a longer time than directedHeart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.Do not use O if you have ever had an allergic reaction to any other pain reliever/fever reducer O right before or after surgery **
*Thi
s pr
oduc
t is
not m
anuf
actu
red
or d
istri
bute
d by
the
owne
rs o
f ALE
VE® L
iqui
d Ge
ls.
**liquid-fill d capsuletrengt h
5”
h
.125” corner radius
Front
2.375”
to last 12 hourshh
55”
1880 cac psules** **liquid-filled capsule
strengt
pain reliever/fever reducer
naproxen sodiumcapsules, 220 mg(NSAID)
6.25”
BackBack
2.375”2.375”
Drug
Fac
ts (c
ontin
ued)
Ask a
docto
r befo
re us
e if O
stom
ach b
leedin
g warn
ing ap
plies
to yo
uO
you h
ave a
histo
ry of
stom
ach p
roble
ms,
such
as he
artbu
rn O
you h
ave
high b
lood p
ressu
re, he
art di
seas
e, liv
er cir
rhos
is, ki
dney
dise
ase,
asthm
a, or
had a
stro
ke O
you a
re tak
ing a
diuret
ic O
you h
ave p
roble
ms o
rse
rious
side
effec
ts fro
m ta
king p
ain re
lieve
rs or
feve
r red
ucers
Ask a
docto
r or p
harm
acist
befor
e use
if yo
u are
O
unde
r a do
ctor's
care
for an
y seri
ous c
ondit
ion O
takin
g asp
irin fo
r hea
rt att
ack o
r stro
ke,
beca
use n
apro
xen m
ay de
creas
e this
bene
fit of
aspir
in O
takin
g any
othe
rdr
ugW
hen u
sing t
his pr
oduc
t O
take
with
food
or m
ilk if
stom
ach u
pset
occu
rsSt
op us
e and
ask a
docto
r if
O yo
u exp
erien
ce an
y of t
he fo
llowi
ng si
gns o
f stom
ach b
leedin
g:O
feel
faint
O vo
mit b
lood
O ha
ve bl
oody
or bl
ack s
tools
O ha
ve st
omac
h pain
that
does
not g
et be
tter
O yo
u hav
e sym
ptom
s of h
eart
prob
lems o
r stro
ke:
O ch
est p
ain O
trou
ble br
eathi
ng O
wea
knes
s in o
ne pa
rt or
side
of bo
dyO
slur
red sp
eech
O
leg s
wellin
g O
pain
gets
worse
or la
sts m
ore t
han 1
0 day
s O
feve
r gets
wor
se or
lasts
mor
e tha
n 3 da
ys O
redn
ess o
r swe
lling i
s pres
ent in
the p
ainful
area
O an
y new
sym
ptom
s app
ear
O yo
u hav
e diffi
culty
swall
owing
O it
feels
like t
he ca
psule
is st
uck i
n you
r thr
oat
If pr
egna
nt or
brea
st-fee
ding,
ask a
healt
h pro
fessio
nal b
efore
use.
It is
espe
cially
impo
rtant
not t
o use
napr
oxen
sodiu
m du
ring t
he la
st 3 m
onths
ofpr
egna
ncy u
nless
defin
itely
direc
ted to
do so
by a
docto
r bec
ause
it m
ayca
use p
roble
ms i
n the
unbo
rn ch
ild or
com
plica
tions
durin
g deli
very.
Keep
out o
f rea
ch of
child
ren.
In ca
se of
overd
ose,
get m
edica
l help
orco
ntact
a Pois
on C
ontro
l Cen
ter ri
ght a
way.
Dire
ction
s O
do no
t tak
e mor
e tha
n dire
cted
O th
e sm
alles
t eff
ectiv
e dos
e sho
uld be
used
O
drink
a ful
l glas
s of w
ater w
ith ea
ch do
seO
if tak
en w
ith fo
od, th
is pr
oduc
t may
take
long
er to
work
Othe
r info
rmati
on O
each
caps
ule co
ntains
: sod
ium 20
mg
O st
ore a
t 20-
25°C
(68-
77°F
) avo
id hig
h hum
idity
and e
xces
sive h
eat a
bove
40°C
(104
°F).
O Pr
otect
from
light.
O
read
all d
irecti
ons a
nd w
arning
s befo
reus
e. Inacti
ve in
gred
ients
FD&C
blue
#1, g
elatin
, glyc
erin,
lactic
acid,
man
nitol,
pharm
aceu
tical
ink, p
olyeth
ylene
glyc
ol, po
vidon
e, pr
opyle
ne gl
ycol,
purif
ied w
ater,
sorb
itan,
sorb
itol
Ques
tions
or co
mm
ents?
1-88
8-23
5-24
66 (M
on -
Fri 9A
M -5
PM ES
T)
adult
s and
child
ren 12
years
and
older:
O ta
ke 1
caps
ule ev
ery 8
to 12
hour
s whil
e sym
ptom
s las
tO
for t
he fir
st do
se yo
u may
take
2 ca
psule
s with
in the
first
hour
O do
not e
xcee
d 2 ca
psule
s in a
ny 8-
to 12
-hou
r peri
odO
do no
t exc
eed 3
caps
ules i
n a 24
-hou
r peri
odO
ask a
docto
rch
ildren
unde
r12
years
:
6.25”6.25”
BIONPHARMA Labeling Format Information:
Fonts: Helvetica Condensed Bold, Helvetica Condensed, Helvetica Condensed Bold Oblique
Drug Facts: 9pt Header: 8pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): N/A
Horizontal Scale: 85% Average Kerning: 0%
Leading: 6.5pt Bullets: 5pt Barlines: 2pt Hairlines: .5pt
Reference ID: 4601010
Lot No :
Exp. Date:
Do
no
t use if p
rinted
safety seal un
der
cap is to
rn o
r missin
g.
pain reliever/fever reducer
naproxen sodiumcapsules, 220 m
g(N
SAID)
Manufactured for: BION PHARMA 600 Alexander Road, Princeton, NJ 08540
R0220
6 9 4 5 2 2 7 0 1 13 0
L0000000
Drug Facts (continued)
O the stomach bleeding warning applies to you O you have a history of stomach problems, such as heartburn O you have high blood pressure, heart disease, liver cirrhosis,
kidney disease, asthma, or had a stroke O you are taking a diuretic O you have problems or serious side effects from taking pain
relievers or fever reducers Ask a doctor or pharmacist before use if you are O under a doctor's care for any serious condition O taking aspirin for heart attack or stroke, because naproxen
may decrease this benefit of aspirin O taking any other drug When using this product O take with food or milk if stomach upset occurs Stop use and ask a doctor if O you experience any of the following signs of stomach
bleeding: O feel faint O vomit blood O have bloody or black stools O have stomach pain that does not get better O you have symptoms of heart problems or stroke: O chest pain O trouble breathing O weakness in one part or side of body O slurred speech O leg swelling O pain gets worse or lasts more than 10 days O fever gets worse or lasts more than 3 days O you have difficu ty swallowing O it feels like the capsule is stuck in your throat O redness or swelling is present in the painful area O any new symptoms appear
Do not use O if you have ever had an allergic reaction to any other pain reliever fever reducer O right before or a ter heart surgery Ask a doctor before use if
**liquid-filled capsule
NDC 69452-270-11
temporarily relieves m
inor cramps,
backache, and headache20 capsules**
12 hour menstrual pain relief
naproxen sodiumcapsules, 220 m
g (NSAID
)pain reliever/fever reducer
Actual Size
Drug Facts Active ingredient (in each capsule) Purposes Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*... .....Pain reliever fever reducer *nonsteroidal anti-inflammatory drug
Uses O temporarily relieves minor aches and pains due to: O menstrual cramps O muscular aches O headache O backache O minor pain of arthritis O toothache O the common cold
O temporarily reduces fever
Naproxen sodium may cause a severe allergic reaction, especially in people a lergic to aspirin. Symptoms may include: Ohives O facial swelling O asthma (wheezing) O shock O skin reddening O rash O blisters If an a lergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or older O have had stomach ulcers or bleeding problems O take a blood thinning (anticoagulant) or steroid drug O take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) O have 3 or more alcoholic drinks every day while using this product O take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Warnings Allergy alert:
Drug Facts (continued) If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
O the smallest effective dose should be used O drink a fu l glass of water with each dose O if taken with food, this product may take longer to work
Directions O do not take more than directed
under 12 years
O ask a doctor
adults and children 12 years and older
O take 1 capsule every 8 hours to 12 hours while symptoms last
O for the first dose you may take 2 capsules within the first hour
O do not exceed 2 capsules in any 8-hour to 12-hour period
O do not exceed 3 capsules in a 24-hour period
Other information O each capsule contains: sodium 20 mg O store at 20° to 25°C (68° to 77°F). Avoid high humidity and
excessive heat above 40°C (104°F). O Protect from light. O read a l directions and warnings before use. Keep carton.
Inactive ingredients FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Questions or comments? call to l free 1-888-235-2466 (Mon‐Fri 9 AM‐5 PM EST)
BIONPHARMA
Labeling Format Information:
Fonts: Helvetica Condensed Bold, Helvetica Condensed, Helvetica Condensed Bold Oblique Georgia
Drug Facts: 8pt Header: 7pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): 7pt
Horizontal Scale: 100% Average Kerning: 0%
Leading: 7pt Bullets: 5pt Barlines: 0.6pt Hairlines: 0.2pt
Reference ID: 4601010
.
Lot No :
Exp. Date:
Do
no
t use if p
rinted
safety seal un
der
cap is to
rn o
r missin
g.
pain reliever/fever reducer
naproxen sodiumcapsules, 220 m
g(N
SAID)
Manufactured for: BION PHARMA 600 Alexander Road, Princeton, NJ 08540
R0220
6 9 4 5 2 2 7 0 1 13 0
L0000000 ***This product is not manufactured or distributed by the owners of Menst idolTM
Drug Facts (continued)
O the stomach bleeding warning applies to you O you have a history of stomach problems, such as heartburn O you have high blood pressure, heart disease, liver cirrhosis,
kidney disease, asthma, or had a stroke O you are taking a diuretic O you have problems or serious side effects from taking pain
relievers or fever reducers Ask a doctor or pharmacist before use if you are O under a doctor's care for any serious condition O taking aspirin for heart attack or stroke, because naproxen
may decrease this benefit of aspirin O taking any other drug When using this product O take with food or milk if stomach upset occurs Stop use and ask a doctor if O you experience any of the following signs of stomach
bleeding: O feel faint O vomit blood O have bloody or black stools O have stomach pain that does not get better O you have symptoms of heart problems or stroke: O chest pain O trouble breathing O weakness in one part or side of body O slurred speech O leg swelling O pain gets worse or lasts more than 10 days O fever gets worse or lasts more than 3 days O you have difficu ty swallowing O it feels like the capsule is stuck in your throat O redness or swelling is present in the painful area O any new symptoms appear
Do not use O if you have ever had an allergic reaction to any other pain reliever fever reducer O right before or a ter heart surgery Ask a doctor before use if
**liquid-filled capsule
NDC 69452-270-11
temporarily relieves m
inor cramps,
backache, and headache20 capsules**
12 hour menstrual pain relief
naproxen sodiumcapsules, 220 m
g (NSAID
)pain reliever/fever reducer
***compare to the active ingredient in M
enstridol TM
Actual Size
Drug Facts Active ingredient (in each capsule) Purposes Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*... .....Pain reliever fever reducer *nonsteroidal anti-inflammatory drug
Uses O temporarily relieves minor aches and pains due to: O menstrual cramps O muscular aches O headache O backache O minor pain of arthritis O toothache O the common cold
O temporarily reduces fever
Naproxen sodium may cause a severe allergic reaction, especially in people a lergic to aspirin. Symptoms may include: Ohives O facial swelling O asthma (wheezing) O shock O skin reddening O rash O blisters If an a lergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or older O have had stomach ulcers or bleeding problems O take a blood thinning (anticoagulant) or steroid drug O take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) O have 3 or more alcoholic drinks every day while using this product O take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Warnings Allergy alert:
Drug Facts (continued) If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
O the smallest effective dose should be used O drink a fu l glass of water with each dose O if taken with food, this product may take longer to work
Directions O do not take more than directed
under 12 years
O ask a doctor
adults and children 12 years and older
O take 1 capsule every 8 hours to 12 hours while symptoms last
O for the first dose you may take 2 capsules within the first hour
O do not exceed 2 capsules in any 8-hour to 12-hour period
O do not exceed 3 capsules in a 24-hour period
Other information O each capsule contains: sodium 20 mg O store at 20° to 25°C (68° to 77°F). Avoid high humidity and
excessive heat above 40°C (104°F). O Protect from light. O read a l directions and warnings before use. Keep carton.
Inactive ingredients FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Questions or comments? call to l free 1-888-235-2466 (Mon‐Fri 9 AM‐5 PM EST)
BIONPHARMA Labeling Format Information:
Fonts: Helvetica Condensed Bold, Helvetica Condensed, Helvetica Condensed Bold Oblique Georgia
Drug Facts: 8pt Header: 7pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): 7pt
Horizontal Scale: 100% Average Kerning: 0%
Leading: 7pt Bullets: 5pt Barlines: 0.6pt Hairlines: 0.2pt
Reference ID: 4601010
Lot No :
Exp. Date:
Do
no
t use if p
rinted
safety seal un
der
cap is to
rn o
r missin
g.
pain reliever/fever reducer
6 9 4 5 2 2 7 0 1 53 8
naproxen sodiumcapsules, 220 m
g(N
SAID)
Drug Facts (continued)
O the stomach bleeding warning app ies to you O you have a history of stomach prob ems, such as heartburn O you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke O you are taking a diuretic O you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are O under a doctor's care for any serious condition O taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin O taking any other drug When using this product O take with food or milk if stomach upset occurs Stop use and ask a doctor if O you experience any of the fo lowing signs of stomach
bleeding: O feel faint O vomit blood O have bloody or black stoo s O have stomach pain that does not get better O you have symptoms of heart problems or stroke: O chest pain O troub e breathing O weakness in one part or side of body O s urred speech O leg swelling O pain gets worse or lasts more than 0 days O fever gets worse or lasts more than 3 days O you have difficu ty swa lowing O it fee s ike the capsule is stuck in your throat O redness or swelling is present in the painful area O any new symptoms appear f pregnant or breast feeding, ask a health professional
before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn chi d or comp ications during delivery.
Ask a doctor before use if
Keep out of reach of children. n case of overdose, get medical he p or contact a Poison Control Center right away.
Manufactured for: BION PHARMA
R0220 600 Alexander Road, Princeton, NJ 08540
L0000000
O take 1 capsule every 8 hours to 2 hours whi e symptoms last O for the first dose you may take 2 capsules
within the first hour O do not exceed 2 capsules in any 8-hour to
12-hour period O do not exceed 3 capsules in a 24-hour
period
adu ts and chi dren 12 years and older
Drug Facts (continued)
Other information O each capsule contains: sodium 20 mg O store at 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat above 40°C ( 04°F). O Protect from ight. O read all directions and warnings before use. Keep carton.
Inactive ingredients FD&C b ue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethy ene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Questions or comments? call toll free 1 888 235 2466 (Mon - Fri 9AM - 5PM EST)
Directions O do not take more than directed O the sma lest effective dose should be used O drink a full glass of water with each dose O if taken with food, this product may take longer to work under 2 years
O ask a doctor
**liquid-filled capsule
NDC 69452-270-15
temporarily relieves m
inor cramps,
backache, and headache40 capsules** 12 hour m
enstrual pain relief
naproxen sodiumcapsules, 220 m
g (NSAID
)pain reliever/fever reducer
Actual Size
Drug Facts Ac ive ingredient (in each capsule) Purposes Nap oxen sodium 220 mg naproxen 200 mg (NSAID)*. .. .. . .. .. .. ..Pain re iever fever reducer
*nonsteroidal anti-inflammatory d ug
Uses O temporarily relieves minor aches and pains due to: O menstrual cramps O muscular aches O headache O backache O minor pain of arthritis O toothache O the common cold
O temporarily reduces fever
Naproxen sodium may cause a severe al ergic reaction, especially in people al ergic to aspirin. Symptoms may include: O hives O facial swe ling O asthma wheezing) O shock O skin reddening O rash O blisters
If an a lergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or older O have had stomach u cers or bleeding problems O take a blood thinning (anticoagulant) or steroid drug O take other drugs containing prescription or nonprescription NSAIDs aspirin, ibuprofen, naproxen, or others) O have 3 or
more alcoholic drinks every day while using this product O take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart fai ure, and stroke. These can be fatal. The risk is higher if you use more than directed or for onger than directed.
Warnings Allergy alert:
Do not use O if you have ever had an al ergic reaction to any other pain re iever/fever reducer O right before or after heart surgery
BIONPHARMA
Labeling Format Information:
Fonts: Helvetica Condensed Bold, Helvetica Condensed, Helvetica Condensed Bold Oblique Georgia
Drug Facts: 8pt Header: 7pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): 7pt
Horizontal Scale: 100% Average Kerning: 0%
Leading: 7pt Bullets: 5pt Barlines: 0.6pt Hairlines: 0.2pt
Reference ID: 4601010
M.
Lot No :
Exp. Date:
Do
no
t use if p
rinted
safety seal un
der
cap is to
rn o
r missin
g.
pain reliever/fever reducer
6 9 4 5 2 2 7 0 1 53 8
naproxen sodiumcapsules, 220 m
g(N
SAID)
** This product is not manufactured or distributed by the owners of Men tridol
Drug Facts (continued)
O the stomach bleeding warning app ies to you O you have a history of stomach prob ems, such as heartburn O you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke O you are taking a diuretic O you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are O under a doctor's care for any serious condition O taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin O taking any other drug When using this product O take with food or milk if stomach upset occurs Stop use and ask a doctor if O you experience any of the fo lowing signs of stomach
bleeding: O feel faint O vomit blood O have bloody or black stoo s O have stomach pain that does not get better O you have symptoms of heart problems or stroke: O chest pain O troub e breathing O weakness in one part or side of body O s urred speech O leg swelling O pain gets worse or lasts more than 0 days O fever gets worse or lasts more than 3 days O you have difficu ty swa lowing O it fee s ike the capsule is stuck in your throat O redness or swelling is present in the painful area O any new symptoms appear f pregnant or breast feeding, ask a health professional
before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn chi d or comp ications during delivery.
Ask a doctor before use if
Keep out of reach of children. n case of overdose, get medical he p or contact a Poison Control Center right away.
Manufactured for: BION PHARMA
R0220
O take 1 capsule every 8 hours to 2 hours whi e symptoms last O for the first dose you may take 2 capsules
within the first hour O do not exceed 2 capsules in any 8-hour to
12-hour period O do not exceed 3 capsules in a 24-hour
period
adu ts and chi dren 12 years and older
Drug Facts (continued)
Other information O each capsule contains: sodium 20 mg O store at 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat above 40°C ( 04°F). O Protect from ight. O read all directions and warnings before use. Keep carton.
Inactive ingredients FD&C b ue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethy ene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Questions or comments? call toll free 1 888 235 2466 (Mon - Fri 9AM - 5PM EST)
Directions O do not take more than directed O the sma lest effective dose should be used O drink a full glass of water with each dose O if taken with food, this product may take longer to work under 2 years
O ask a doctor
600 Alexander Road, Princeton, NJ 08540
L0000000
**liquid-filled capsule
NDC 69452-270-15
temporarily relieves m
inor cramps,
backache, and headache40 capsules** 12 hour m
enstrual pain relief
naproxen sodiumcapsules, 220 m
g (NSAID
)pain reliever/fever reducer
***compare to the active ingredient in M
enstridol TM
Actual Size
Drug Facts Ac ive ingredient (in each capsule) Purposes Nap oxen sodium 220 mg naproxen 200 mg (NSAID)*. .. .. . .. .. .. ..Pain re iever fever reducer
*nonsteroidal anti-inflammatory d ug
Uses O temporarily relieves minor aches and pains due to: O menstrual cramps O muscular aches O headache O backache O minor pain of arthritis O toothache O the common cold
O temporarily reduces fever
Naproxen sodium may cause a severe al ergic reaction, especially in people al ergic to aspirin. Symptoms may include: O hives O facial swe ling O asthma wheezing) O shock O skin reddening O rash O blisters
If an a lergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or older O have had stomach ulcers or bleeding problems O take a blood thinning (anticoagulant) or steroid drug O take other drugs containing prescription or nonprescription NSAIDs aspirin, ibuprofen, naproxen, or others) O have 3 or
more alcoholic drinks every day while using this product O take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart fai ure, and stroke. These can be fatal. The risk is higher if you use more than directed or for onger than directed.
Warnings Allergy alert:
Do not use O if you have ever had an al ergic reaction to any other pain re iever/fever reducer O right before or after heart surgery
BIONPHARMA Labeling Format Information:
Fonts: Helvetica Condensed Bold, Helvetica Condensed, Helvetica Condensed Bold Oblique Georgia
Drug Facts: 8pt Header: 7pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): 7pt
Horizontal Scale: 100% Average Kerning: 0%
Leading: 7pt Bullets: 5pt Barlines: 0.6pt Hairlines: 0.2pt
Reference ID: 4601010
pain reliever/fever reducer
Do
no
t use if p
rinted
safety seal un
der
cap is to
rn o
r missin
g.
6 9 4 5 2 2 7 0 7 8 3 3
naproxen sodiumcapsules, 220 m
g(N
SAID)
Lot No.:
Exp. Date:
Drug Facts (continued)
Ask a doctor or pharmacist before use if you are O under a doctor's care for any serious condition O taking aspirin for heart attack or stroke, because naproxen
may decrease this benefit of aspirin O taking any other drug When using this product O take with food or milk if stomach upset occurs
Do not use O if you have ever had an allergic reaction to any other pain reliever fever reducer O right before or after heart surgery Ask a doctor before use if O the stomach bleeding warning applies to you O you have a history of stomach problems, such as heartburn O you have high blood pressure, heart disease, liver cirrhosis,
kidney disease, asthma, or had a stroke O you are taking a diuretic O you have problems or serious side effects from taking pain relievers or fever reducers
Stop use and ask a doctor if O you experience any of the following signs of stomach bleeding: O feel faint O vomit blood O have bloody or black stools O have stomach pain that does not get better
O you have symptoms of heart problems or stroke: O chest pain
O O trouble breathing
weakness in one part or side of body O slurred speech O leg swelling
O pain gets worse or lasts more than 10 days O fever gets worse or lasts more than 3 days O
redness or swelling is present in the painful area O
any new symptoms appear O
you have difficulty swallowing
O
it feels like the capsule is stuck in your throat
If pregnant or breast feeding, ask a hea th professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. R0220
Manufactured for:BIONPHARMA 600 Alexander Road, Princeton, NJ 08540
Drug Facts (continued)
Inactive ingredients FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Questions or comments? call to l-free 1 888 235 2466 (Mon - Fri 9AM - 5PM EST)
O read a l directions and warnings before use. Keep carton.
Other information O each capsule contains: sodium 20 mg O store at 20° to 25°C (68° to 77°F). Avoid high humidity and
excessive heat above 40°C (104°F). O Protect from light.
O take 1 capsule every 8 hours to 12 hours while symptoms last O for the first dose you may take
2 capsules within the first hour O do not exceed 2 capsules in any 8-hour
to 12-hour period O do not exceed 3 capsules in a 24-hour
period
adults and children 12 years and older
under 12 years O ask a doctor
O drink a full glass of water with each dose O if taken with food, this product may take longer to work
Directions O do not take more than directed O the smallest effective dose should be used
L0000000
**liquid-filled capsule
NDC 69452-270-78
temporarily relieves m
inor cramps,
backache, and headache80 capsules** 12 hour m
enstrual pain relief
naproxen sodiumcapsules, 220 m
g (NSAID
)pain reliever/fever reducer
Actual Size
Drug Facts Active ingredient (in each capsule) Purposes Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*............Pain reliever fever reducer *nonsteroidal anti-inflammatory drug
Uses
Warnings Allergy alert: Naproxen sodium may cause a severe a lergic reaction, especially in people allergic to aspirin. Symptoms may include: O hives O facial swelling O asthma (wheezing) O shock O skin reddening O rash O blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or older O have had stomach ulcers or bleeding problems O take a blood thinning (anticoagulant) or steroid drug O take other drugs containing prescription or nonprescription
NSAIDs (aspirin, ibuprofen, naproxen, or others) O have 3 or more alcoholic drinks every day while using this
product O take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
O temporarily relieves minor aches and pains due to: O menstrual cramps O muscular aches O headache O backache O minor pain of arthritis O toothache O the common cold
O temporarily reduces fever
BIONPHARMA
Labeling Format Information:
Fonts: Helvetica Condensed Bold, Helvetica Condensed, Helvetica Condensed Bold Oblique Georgia
Drug Facts: 8pt Header: 7pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): 7pt
Horizontal Scale: 100% Average Kerning: 0%
Leading: 7pt Bullets: 5pt Barlines: 0.6pt Hairlines: 0.2pt
Reference ID: 4601010
.
pain reliever/fever reducer
Do
no
t use if p
rinted
safety seal un
der
cap is to
rn o
r missin
g.
6 9 4 5 2 2 7 0 7 8 3 3
naproxen sodiumcapsules, 220 m
g(N
SAID)
***This product is not manufactured or distributed by the owners of MenstridolTM
Drug Facts (continued)
Ask a doctor or pharmacist before use if you are O under a doctor's care for any serious condition O taking aspirin for heart attack or stroke, because naproxen
may decrease this benefit of aspirin O taking any other drug When using this product O take with food or milk if stomach upset occurs
Do not use O if you have ever had an allergic reaction to any other pain reliever fever reducer O right before or after heart surgery Ask a doctor before use if O the stomach bleeding warning applies to you O you have a history of stomach problems, such as heartburn O you have high blood pressure, heart disease, liver cirrhosis,
kidney disease, asthma, or had a stroke O you are taking a diuretic O you have problems or serious side effects from taking pain relievers or fever reducers
Stop use and ask a doctor if O you experience any of the following signs of stomach bleeding: O feel faint O vomit blood O have bloody or black stools O have stomach pain that does not get better
O you have symptoms of heart problems or stroke: O chest pain
O O trouble breathing
weakness in one part or side of body O slurred speech O leg swelling
O pain gets worse or lasts more than 10 days O fever gets worse or lasts more than 3 days O
redness or swelling is present in the painful area O
any new symptoms appear O
you have difficulty swallowing
O
it feels like the capsule is stuck in your throat
If pregnant or breast feeding, ask a hea th professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. R0220
Manufactured for:BIONPHARMA 600 Alexander Road, Princeton, NJ 08540
Drug Facts (continued)
Inactive ingredients FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Questions or comments? call to l-free 1 888 235 2466 (Mon - Fri 9AM - 5PM EST)
O read a l directions and warnings before use. Keep carton.
Other information O each capsule contains: sodium 20 mg O store at 20° to 25°C (68° to 77°F). Avoid high humidity and
excessive heat above 40°C (104°F). O Protect from light.
O take 1 capsule every 8 hours to 12 hours while symptoms last O for the first dose you may take
2 capsules within the first hour O do not exceed 2 capsules in any 8-hour
to 12-hour period O do not exceed 3 capsules in a 24-hour
period
adults and children 12 years and older
under 12 years O ask a doctor
O drink a full glass of water with each dose O if taken with food, this product may take longer to work
Directions O do not take more than directed O the smallest effective dose should be used
L0000000
**liquid-filled capsule
NDC 69452-270-78
temporarily relieves m
inor cramps,
backache, and headache80 capsules** 12 hour m
enstrual pain relief
naproxen sodiumcapsules, 220 m
g (NSAID
)pain reliever/fever reducer
***compare to the active ingredient in M
enstridol TM
Actual Size
Drug Facts Active ingredient (in each capsule) Purposes Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*............Pain reliever fever reducer *nonsteroidal anti-inflammatory drug
Uses
Warnings Allergy alert: Naproxen sodium may cause a severe a lergic reaction, especially in people allergic to aspirin. Symptoms may include: O hives O facial swelling O asthma (wheezing) O shock O skin reddening O rash O blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or older O have had stomach ulcers or bleeding problems O take a blood thinning (anticoagulant) or steroid drug O take other drugs containing prescription or nonprescription
NSAIDs (aspirin, ibuprofen, naproxen, or others) O have 3 or more alcoholic drinks every day while using this
product O take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
O temporarily relieves minor aches and pains due to: O menstrual cramps O muscular aches O headache O backache O minor pain of arthritis O toothache O the common cold
O temporarily reduces fever
Lot No.:
Exp. Date:
BIONPHARMA Labeling Format Information:
Fonts: Helvetica Condensed Bold, Helvetica Condensed, Helvetica Condensed Bold Oblique Georgia
Drug Facts: 8pt Header: 7pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): 7pt
Horizontal Scale: 100% Average Kerning: 0%
Leading: 7pt Bullets: 5pt Barlines: 0.6pt Hairlines: 0.2pt
Reference ID: 4601010
Lot No.:
Exp. Date:
Manufactured for:
BIONPHARMA 600 Alexander Road, Princeton, NJ 08540
Drug Facts Active ingredient (in each capsule) Purposes Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* .... ..... .... ..Pain reliever fever reducer *nonsteroidal anti-inflammatory drug
Uses O temporarily relieves minor aches and pains due to: O backache O muscular aches O minor pain of arthritis O menstrual cramps O headache O toothache O the common cold O temporarily reduces fever
Warnings Allergy alert Naproxen sodium may cause a severe a lergic reaction, especia ly in people allergic to aspirin. Symptoms may include: O hives O facial swelling O asthma (wheezing) O shock O skin reddening O rash O blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or older O have had stomach ulcers or bleeding problems O take a blood thinning (anticoagulant) or steroid drug O take other drugs containing prescription or nonprescription
NSAIDs (aspirin, ibuprofen, naproxen, or others) O have 3 or more alcoholic drinks every day while using this product O take more or for a longer time than directed
Drug Facts (continued)
Ask a doctor or pharmacist before use f you are O under a doctor's care for any serious condition O taking aspirin for heart attack or stroke, because naproxen may
decrease this benefit of aspirin O taking any other drug
When using this product O take with food or milk if stomach upset occurs
Drug Facts (continued)
Inactive ingredients FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Questions or comments? call to l free 1 888 235 2466 (Mon - Fri 9AM - 5PM EST)
R0220
L0000000
Ask a doctor before use if O the stomach bleeding warning applies to you O you have a history of stomach problems, such as heartburn O you have high blood pressure, heart disease, liver cirrhosis,
kidney disease, asthma, or had a stroke O you are taking a diuretic O you have problems or serious side effects from taking pain relievers or fever reducers
Stop use and ask a doctor if O you experience any of the fo lowing signs of stomach
bleeding: O feel faint O vomit blood O have bloody or black stools O have stomach pain that does not get better O you have symptoms of heart problems or stroke: O chest pain O trouble breathing O weakness in one part or side of body O slurred speech O leg swe ling O pain gets worse or lasts more than 0 days O fever gets worse or lasts more than 3 days O you have difficulty swa lowing O it feels like the capsule is stuck in your throat O redness or swelling is present in the painful area O any new symptoms appear
Do
no
t use if p
rinted
safety seal un
der
cap is to
rn o
r missin
g.
f pregnant or breast feeding, ask a health profess onal before use. t is especia ly important not to use naproxen sodium during the last
3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Heart a tack and stroke warning NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use O if you have ever had an allergic reaction to any other pain reliever fever reducer O right before or after heart surgery
Other information O each capsule contains sodium 20 mg O store at 20° to 25°C (68° to 77°F). Avoid high humidity and
excessive heat above 40°C (104°F). O Protect from light. O read a l directions and warnings before use. Keep carton.
O take 1 capsule every 8 hours to 2 hours wh le symptoms last O for the first dose you may take 2 capsules within
the first hour O do not exceed 2 capsules in any 8-hour to 12-hour
period O do not exceed 3 capsules in a 24-hour period
Adults and children 12 years and older
Ch ldren under 12 years
O ask a doctor
Directions O do not take more than directed O the sma lest effec ive dose should be used O drink a full glass of water with each dose O if taken with food, this product may take longer to work
NDC 69452-269-16
for temporary relief of m
inor backand m
uscle aches and pains
12 hour back & muscle pain relief
naproxen sodiumcapsules, 220 m
g (NSAID
)pain reliever/fever reducer
pain reliever/fever reducer
50 capsules****liquid-filled capsule
6 9 4 5 2 2 6 9 1 63 9
naproxen sodiumcapsules, 220 m
g(N
SAID)
Actual Size
BIONPHARMA
Labeling Format Information:
Fonts: Helvetica Condensed Bold, Helvetica Condensed, Helvetica Condensed Bold Oblique Georgia
Drug Facts: 8pt Header: 7pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): 7pt
Horizontal Scale: 100% Average Kerning: 0%
Leading: 7pt Bullets: 5pt Barlines: 0.6pt Hairlines: 0.2pt
Reference ID: 4601010
Lot No.:
Exp. Date:
Manufactured for:
BIONPHARMA 600 Alexander Road, Princeton, NJ 08540
Drug Facts Active ingredient (in each capsule) Purposes Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* .... ..... .... ..Pain reliever fever reducer *nonsteroidal anti-inflammatory drug
Uses O temporarily relieves minor aches and pains due to: O backache O muscular aches O minor pain of arthritis O menstrual cramps O headache O toothache O the common cold O temporarily reduces fever
Warnings Allergy alert Naproxen sodium may cause a severe a lergic reaction, especia ly in people allergic to aspirin. Symptoms may include: O hives O facial swelling O asthma (wheezing) O shock O skin reddening O rash O blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or older O have had stomach ulcers or bleeding problems O take a blood thinning (anticoagulant) or steroid drug O take other drugs containing prescription or nonprescription
NSAIDs (aspirin, ibuprofen, naproxen, or others) O have 3 or more alcoholic drinks every day while using this product O take more or for a longer time than directed
Drug Facts (continued)
Ask a doctor or pharmacist before use f you are O under a doctor's care for any serious condition O taking aspirin for heart attack or stroke, because naproxen may
decrease this benefit of aspirin O taking any other drug
When using this product O take with food or milk if stomach upset occurs
Drug Facts (continued)
Inactive ingredients FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Questions or comments? call to l free 1 888 235 2466 (Mon - Fri 9AM - 5PM EST)
R0220
L0000000
Ask a doctor before use if O the stomach bleeding warning applies to you O you have a history of stomach problems, such as heartburn O you have high blood pressure, heart disease, liver cirrhosis,
kidney disease, asthma, or had a stroke O you are taking a diuretic O you have problems or serious side effects from taking pain relievers or fever reducers
Stop use and ask a doctor if O you experience any of the fo lowing signs of stomach
bleeding: O feel faint O vomit blood O have bloody or black stools O have stomach pain that does not get better O you have symptoms of heart problems or stroke: O chest pain O trouble breathing O weakness in one part or side of body O slurred speech O leg swe ling O pain gets worse or lasts more than 0 days O fever gets worse or lasts more than 3 days O you have difficulty swa lowing O it feels like the capsule is stuck in your throat O redness or swelling is present in the painful area O any new symptoms appear
Do
no
t use if p
rinted
safety seal un
der
cap is to
rn o
r missin
g.
f pregnant or breast feeding, ask a health profess onal before use. t is especia ly important not to use naproxen sodium during the last
3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Heart a tack and stroke warning NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use O if you have ever had an allergic reaction to any other pain reliever fever reducer O right before or after heart surgery
Other information O each capsule contains sodium 20 mg O store at 20° to 25°C (68° to 77°F). Avoid high humidity and
excessive heat above 40°C (104°F). O Protect from light. O read a l directions and warnings before use. Keep carton.
O take 1 capsule every 8 hours to 2 hours wh le symptoms last O for the first dose you may take 2 capsules within
the first hour O do not exceed 2 capsules in any 8-hour to 12-hour
period O do not exceed 3 capsules in a 24-hour period
Adults and children 12 years and older
Ch ldren under 12 years
O ask a doctor
Directions O do not take more than directed O the sma lest effec ive dose should be used O drink a full glass of water with each dose O if taken with food, this product may take longer to work
NDC 69452-269-16
for temporary relief of m
inor backand m
uscle aches and pains
12 hour back & muscle pain relief
naproxen sodiumcapsules, 220 m
g (NSAID
)pain reliever/fever reducer
pain reliever/fever reducer
50 capsules****liquid-filled capsule
6 9 4 5 2 2 6 9 1 63 9
naproxen sodiumcapsules, 220 m
g(N
SAID)
***Compare to the active ingredient in A
LEVE
® BA
CK &
MU
SCLE PAIN
***This product is not manufactured or distributed by the owners of ALEVE® Back & Muscle pain.
Actual Size
BIONPHARMA Labeling Format Information:
Fonts: Helvetica Condensed Bold, Helvetica Condensed, Helvetica Condensed Bold Oblique Georgia
Drug Facts: 8pt Header: 7pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): 7pt
Horizontal Scale: 100% Average Kerning: 0%
Leading: 7pt Bullets: 5pt Barlines: 0.6pt Hairlines: 0.2pt
Reference ID: 4601010
2.375”2.375”
Reference ID: 4601010
.125” corner radius Front
Drug Facts Active ingredient (in each capsule) Purposes Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*........ ........ ........ .Pain reliever/fever reducer*nonsteroidal anti-inflammatory drug
Uses O temporarily relieves minor aches and pains due to: O backache O muscular aches O minor pain of arthritis O menstrual cramps O headache O toothache O the common cold O temporarily reduces fever
Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: O hives O facial swelling O asthma (wheezing) O shock O skin reddening O rash O blisters If an a lergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or older O have had stomach ulcers or bleeding problems O take a blood thinning (anticoagulant) or steroid drug O take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) O have 3 or more alcoholic drinks every day while using this product O take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use O if you have ever had an allergic reaction to any other pain reliever/fever reducer O right before or after heart surgery
Man
ufac
ture
d fo
r:
BIO
NPH
ARM
A60
0 Al
exan
der R
oad,
Pr
ince
ton,
NJ
0854
03
69452
26920
Lot/E
XP
L000
0000
R0
220
Non
Var
nish
Are
a
2.375”
NDC 69452-269-20
naproxen sodium capsules, 220 mg (NSAID) pain reliever/fever reducer
12 hour back & muscle pain relief Actual Size
100 capsules**
for temporary relief of minor back and muscle aches and pains
Do not use if printed safety seal**liquid-filled capsule under cap is torn or missing.
6.00”
Back
Drug
Fac
ts (c
ontin
ued)
Ask a
docto
r befo
re us
e if O
the s
tomac
h blee
ding w
arning
appli
es to
you
O yo
u hav
e a hi
story
of sto
mac
h pro
blem
s, su
ch as
heart
burn
O
you h
ave
high b
lood p
ressu
re, he
art di
seas
e, liv
er cir
rhos
is, ki
dney
dise
ase,
asthm
a, or
had a
stro
ke O
you a
re tak
ing a
diuret
ic O
you h
ave p
roble
ms o
r seri
ous
side e
ffects
from
takin
g pain
relie
vers
or fe
ver r
educ
ersAs
k a do
ctor o
r pha
rmac
ist be
fore u
se if
you a
re O
unde
r a do
ctor's
care
foran
y seri
ous c
ondit
ion O
takin
g asp
irin fo
r hea
rt att
ack o
r stro
ke, b
ecau
sena
prox
en m
ay de
creas
e this
bene
fit of
aspir
in O
takin
g any
othe
r dru
g
Whe
n usin
g this
prod
uct O
take
with
food
or m
ilk if
stom
ach u
pset
occu
rs
O yo
u exp
erien
ce an
y of th
e fo l
owing
sign
s of s
tomac
h blee
ding:
O fe
el fai
nt O
vom
it bloo
d O
have
bloo
dy or
blac
k stoo
ls O
have
stom
ach p
ain th
at do
es no
t get
bette
rO
you
have
sym
ptom
s of h
eart
prob
lems o
r stro
ke:
O ch
est p
ain O
trou
ble br
eathi
ng O
wea
knes
s in o
ne pa
rt or
side
of bo
dyO
slur
red sp
eech
O le
g swe
lling
O pa
in ge
ts wo
rse or
lasts
mor
e tha
n 10 d
ays O
feve
r gets
wor
se or
lasts
mor
e tha
n 3 da
ys O
you h
ave d
ifficu
lty sw
a low
ing O
it fee
ls lik
e the
caps
uleis
stuck
in yo
ur th
roat O
redn
ess o
r swe
lling i
s pres
ent in
the p
ainful
area
O an
y new
sym
ptom
s app
ear
If pr
egna
nt or
brea
st-fee
ding,
ask a
healt
h pro
fessio
nal b
efore
use.
It is
espe
cially
impo
rtant
not t
o use
napr
oxen
sodiu
m du
ring t
he la
st 3 m
onths
ofpr
egna
ncy u
nless
defin
itely
direc
ted to
do so
by a
docto
r bec
ause
it m
ayca
use p
roble
ms i
n the
unbo
rn ch
ild or
com
plica
tions
durin
g deli
very.
Keep
out o
f rea
ch of
child
ren.
In ca
se of
overd
ose,
get m
edica
l help
orco
ntact
a Pois
on C
ontro
l Cen
ter ri
ght a
way.
Dire
ctio
ns O
do no
t tak
e mor
e tha
n dire
cted O
the s
mall
est e
ffecti
vedo
se sh
ould
be us
ed O
drink
a ful
l glas
s of w
ater w
ith ea
ch do
seO
if tak
en w
ith fo
od, th
is pr
oduc
t may
take
long
er to
work
Othe
r inf
orm
atio
n O
eac
h cap
sule
cont
ains
: sod
ium 20
mg O
stor
e at
20° t
o 25°
C (6
8° to
77°F
). Av
oid hi
gh hu
midi
ty an
d exc
essiv
e hea
t abo
ve40
°C (1
04°F
). O
Prote
ct fro
m lig
ht. O
read
a l d
irecti
ons a
nd w
arnin
gsbe
fore
use.
Inac
tive i
ngre
dients
FD&
C blu
e #1,
gelat
in, gl
yceri
n, lac
tic ac
id, m
annit
ol,ph
armac
eutic
al ink
, poly
ethyle
ne gl
ycol,
povid
one,
prop
ylene
glyc
ol, pu
rified
water
, sor
bitan
, sor
bitol
Ques
tions
or c
omm
ents?
call t
oll-fr
ee 1
-888
-235
-246
6 (M
on -
Fri 9
AM -
5PM
EST
)
Adult
s and
child
ren12
yea
rs an
dold
er
O ta
ke 1
caps
ule ev
ery 8
hour
s to 1
2 hou
rs wh
ile sy
mpto
ms l
ast
O fo
r the
first
dose
you m
ay ta
ke 2
caps
ules w
ithin
the fir
st ho
urO
do no
t exc
eed 2
caps
ules i
n any
8-ho
ur to
12-h
our p
eriod
O do
not e
xcee
d 3 ca
psule
s in a
24-h
our p
eriod
O as
k a d
octo
rCh
ildren
unde
r12
years
Stop
use a
nd as
k a do
ctor i
f
6.00”
BIONPHARMA
Labeling Format Information:
Fonts: Helvetica Condensed Bold, Helvetica Condensed, Helvetica Condensed Bold Oblique Georgia
Drug Facts: 8pt Header: 7pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): 7pt
Horizontal Scale: 100% Average Kerning: 0%
Leading: 5pt Bullets: 5pt Barlines: 0.6pt Hairlines: 0.2pt
6
2.375”2.375”
Reference ID: 4601010
.125” corner radius Front
Drug Facts Active ingredient (in each capsule) Purposes Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*........ ........ ........ .Pain reliever/fever reducer*nonsteroidal anti-inflammatory drug
Uses O temporarily relieves minor aches and pains due to: O backache O muscular aches O minor pain of arthritis O menstrual cramps O headache O toothache O the common cold O temporarily reduces fever
Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: O hives O facial swelling O asthma (wheezing) O shock O skin reddening O rash O blisters If an a lergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: O are age 60 or older O have had stomach ulcers or bleeding problems O take a blood thinning (anticoagulant) or steroid drug O take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) O have 3 or more alcoholic drinks every day while using this product O take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use O if you have ever had an allergic reaction to any other pain reliever/fever reducer O right before or after heart surgery **
*This
prod
uct is
not m
anuf
actu
red o
r dist
ribut
ed by
the o
wner
s of A
LEVE
® B
ack &
Mus
cle pa
in.
Man
ufac
ture
d fo
r:
BIO
NPH
ARM
A60
0 Al
exan
der R
oad,
Pr
ince
ton,
NJ
0854
03
69452
26920
Lot/E
XP
L000
0000
R0
220
Non
Var
nish
Are
a
2.375”
***Compare to the active ingredient in ALEVE® BACK & MUSCLE PAIN
NDC 69452-269-20
naproxen sodium capsules, 220 mg (NSAID) pain reliever/fever reducer
12 hour back & muscle pain relief Actual Size
100 capsules**
for temporary relief of minor back and muscle aches and pains
Do not use if printed safety seal**liquid-filled capsule under cap is torn or missing.
6.00”
Back
Drug
Fac
ts (c
ontin
ued)
Ask a
docto
r befo
re us
e if O
the s
tomac
h blee
ding w
arning
appli
es to
you
O yo
u hav
e a hi
story
of sto
mac
h pro
blem
s, su
ch as
heart
burn
O
you h
ave
high b
lood p
ressu
re, he
art di
seas
e, liv
er cir
rhos
is, ki
dney
dise
ase,
asthm
a, or
had a
stro
ke O
you a
re tak
ing a
diuret
ic O
you h
ave p
roble
ms o
r seri
ous
side e
ffects
from
takin
g pain
relie
vers
or fe
ver r
educ
ersAs
k a do
ctor o
r pha
rmac
ist be
fore u
se if
you a
re O
unde
r a do
ctor's
care
foran
y seri
ous c
ondit
ion O
takin
g asp
irin fo
r hea
rt att
ack o
r stro
ke, b
ecau
sena
prox
en m
ay de
creas
e this
bene
fit of
aspir
in O
takin
g any
othe
r dru
g
Whe
n usin
g this
prod
uct O
take
with
food
or m
ilk if
stom
ach u
pset
occu
rs
O yo
u exp
erien
ce an
y of th
e fo l
owing
sign
s of s
tomac
h blee
ding:
O fe
el fai
nt O
vom
it bloo
d O
have
bloo
dy or
blac
k stoo
ls O
have
stom
ach p
ain th
at do
es no
t get
bette
rO
you
have
sym
ptom
s of h
eart
prob
lems o
r stro
ke:
O ch
est p
ain O
trou
ble br
eathi
ng O
wea
knes
s in o
ne pa
rt or
side
of bo
dyO
slur
red sp
eech
O le
g swe
lling
O pa
in ge
ts wo
rse or
lasts
mor
e tha
n 10 d
ays O
feve
r gets
wor
se or
lasts
mor
e tha
n 3 da
ys O
you h
ave d
ifficu
lty sw
a low
ing O
it fee
ls lik
e the
caps
uleis
stuck
in yo
ur th
roat O
redn
ess o
r swe
lling i
s pres
ent in
the p
ainful
area
O an
y new
sym
ptom
s app
ear
If pr
egna
nt or
brea
st-fee
ding,
ask a
healt
h pro
fessio
nal b
efore
use.
It is
espe
cially
impo
rtant
not t
o use
napr
oxen
sodiu
m du
ring t
he la
st 3 m
onths
ofpr
egna
ncy u
nless
defin
itely
direc
ted to
do so
by a
docto
r bec
ause
it m
ayca
use p
roble
ms i
n the
unbo
rn ch
ild or
com
plica
tions
durin
g deli
very.
Keep
out o
f rea
ch of
child
ren.
In ca
se of
overd
ose,
get m
edica
l help
orco
ntact
a Pois
on C
ontro
l Cen
ter ri
ght a
way.
Dire
ctio
ns O
do no
t tak
e mor
e tha
n dire
cted O
the s
mall
est e
ffecti
vedo
se sh
ould
be us
ed O
drink
a ful
l glas
s of w
ater w
ith ea
ch do
seO
if tak
en w
ith fo
od, th
is pr
oduc
t may
take
long
er to
work
Othe
r inf
orm
atio
n O
eac
h cap
sule
cont
ains
: sod
ium 20
mg O
stor
e at
20° t
o 25°
C (6
8° to
77°F
). Av
oid hi
gh hu
midi
ty an
d exc
essiv
e hea
t abo
ve40
°C (1
04°F
). O
Prote
ct fro
m lig
ht. O
read
a l d
irecti
ons a
nd w
arnin
gsbe
fore
use.
Inac
tive i
ngre
dients
FD&
C blu
e #1,
gelat
in, gl
yceri
n, lac
tic ac
id, m
annit
ol,ph
armac
eutic
al ink
, poly
ethyle
ne gl
ycol,
povid
one,
prop
ylene
glyc
ol, pu
rified
water
, sor
bitan
, sor
bitol
Ques
tions
or c
omm
ents?
call t
oll-fr
ee 1
-888
-235
-246
6 (M
on -
Fri 9
AM -
5PM
EST
)
Adult
s and
child
ren12
yea
rs an
dold
er
O ta
ke 1
caps
ule ev
ery 8
hour
s to 1
2 hou
rs wh
ile sy
mpto
ms l
ast
O fo
r the
first
dose
you m
ay ta
ke 2
caps
ules w
ithin
the fir
st ho
urO
do no
t exc
eed 2
caps
ules i
n any
8-ho
ur to
12-h
our p
eriod
O do
not e
xcee
d 3 ca
psule
s in a
24-h
our p
eriod
O as
k a d
octo
rCh
ildren
unde
r12
years
Stop
use a
nd as
k a do
ctor i
f
6.00”
BIONPHARMA Labeling Format Information:
Fonts: Helvetica Condensed Bold, Helvetica Condensed, Helvetica Condensed Bold Oblique Georgia
Drug Facts: 8pt Header: 7pt Subheader: 6pt Body Text: 6pt Drug Facts (continued): 7pt
Horizontal Scale: 100% Average Kerning: 0%
Leading: 5pt Bullets: 5pt Barlines: 0.6pt Hairlines: 0.2pt
6
--------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------
------------------------------------------------------------
(
Signature Page 1 of 1
This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.
/s/
NUSHIN F TODD 04/30/2020 03:05:23 PM
Reference ID: 4601010