36
20 CAPSULES Actual Size N r Do not use if printed safety seal under cap is torn or missing. r e c u d e R r e v e F / r e v e i l e R n i a P m u i d o S n e x o r p a N g m 0 2 2 , s e l u s p a C ) D I A S N ( Pain Reliever/Fever Reducer Naproxen Sodium Capsules, 220 mg (NSAID) Strength to last 12 hours NDC 69452-179-11 Lot No : Exp. Date: r S r 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 Ostomach bleeding warning applies to you Oyou have a history of stomach problems, such as heartburn Oyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke Oyou are taking a diuretic Oyou have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are Ounder a doctor's care for any serious condition Otaking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin Otaking any other drug When using this product Otake with food or milk if stomach upset occurs Stop use and ask a doctor if Oyou experience any of the fo lowing signs of stomach bleeding: Ofeel faint Ovomit blood Ohave bloody or black stools Ohave stomach pain that does not get better Oyou 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 Othe smallest effective dose should be used Odrink a full glass of water with each dose Oif taken with food, this product may take longer to work Other information O each capsule contains: sodium 20 mg Ostore at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F). OProtect from light. Oread 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 Ochest pain Otrouble breathing Oweakness in one part or side of body Oslurred speech Oleg swelling Opain gets worse or lasts more than 10 days Ofever gets worse or lasts more than 3 days Oredness or swe ling is present in the painful area Oany new symptoms appear Oyou have difficulty swallowing Oit 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 Omuscular aches O backache Omenstrual cramps O headache Otoothache Othe 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 Ofacial swe ling Oasthma (wheezing) O shock Oskin reddening Orash Oblisters 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: Oare age 60 or older Ohave had stomach ulcers or bleeding problems Otake a blood thinning (anticoagulant) or steroid drug Otake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) Ohave 3 or more alcoholic drinks every day while using this product Otake 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

Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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Page 1: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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

Page 2: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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

Page 3: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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

Page 4: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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

Page 5: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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

Page 6: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

40 CAPSULES

Actual Size

SSAID)))

Do not use if printed safety seal under cap istorn or m

issing.

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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

Page 7: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

50 CAPSULES

Actual Size

SSAID)))

Do not use if printed safety seal under cap istorn or m

issing.

r ecu

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niaP

mui d

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m02

2,se

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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

Page 8: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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

Page 9: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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Reference ID: 4601010

Page 10: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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orbi

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itol

Ques

tions

or c

omm

ents

? 1-

888-

235-

2466

(Mon

- Fri

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- 5P

M ES

T)

BIO

NPH

ARM

AL

ab

eli

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Fo

rma

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B

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Reference ID: 4601010

Page 11: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

BIO

NPH

ARM

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ab

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THIS

PACK

AGE F

OR HO

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WITH

OUT Y

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REN

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

ARTHRITIS CAPEASY OPEN

ARTH

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PEA

SYOP

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Pain Reliever/Fever Reducer

Naproxen SodiumCapsules, 220 mg (NSAID)

Strength to last 12 hours

80 CAPSULES

NDC 69452-179-78

Napr

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Reference ID: 4601010

Page 12: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

BIO

NPH

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Compare to the active ingredient of ALEVE® Liquid Gels***

Pain Reliever/Fever Reducer

Naproxen SodiumCapsules, 220 mg (NSAID)

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80 CAPSULES

NDC 69452-179-78

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Lot N

o.:

Exp.

Date

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***T

his

prod

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onta

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n Co

ntro

l Cen

ter r

ight

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ctio

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edO

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ified

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orbi

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itol

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tions

or c

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ents

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235-

2466

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- Fri

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ke 1

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Reference ID: 4601010

Page 13: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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Reference ID: 4601010

Page 14: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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BIO

NPH

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ab

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Reference ID: 4601010

Page 15: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

120 CAPSULES

Actual Size

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:

120 CAPSULES

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NDC 69452 179 22

Pain Reliever/Fever Reducer

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Strength to last 12 hours 120 CAPSULES

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Reference ID: 4601010

Page 16: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

120 CAPSULES

Actual Size

120 CAPSULES

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Drug

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tive

ingr

edie

nt (i

n ea

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psul

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s

Do not use if printed safety seal under cap istorn or missing.

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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

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n Co

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(104

°F).

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rote

ct fr

om lig

ht.

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l dire

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p ca

rton.

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tive

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blu

e #1,

gela

tin, g

lycer

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actic

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nito

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arm

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thyle

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lycol

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idon

e, pr

opyle

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lycol

, pur

ified

wat

er, s

orbi

tan,

sorb

itol

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ke 1

caps

ule e

very

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mpt

oms l

ast

O fo

r the

firs

t dos

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may

take

2 ca

psul

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psul

es in

any 8

- to

2-ho

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erio

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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

:

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nts

: Hel

vetic

a Co

nden

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nden

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elve

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cale

: 100

%

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age

Kern

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0%

Le

ad

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: 7.

2pt

Bu

lle

ts:

5pt

B

arl

ine

s:

.6pt

H

air

lin

es:

.2

pt

Reference ID: 4601010

Page 17: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

160 CAPSULES

Actual Size

160 CAPSULES

Actual Size

Drug

Fac

tsAc

tive

ingr

edie

nt (i

n ea

ch ca

psul

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220

mg

(nap

roxe

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0 m

g) (N

SAID

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... .. .

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.. ..P

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duce

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roida

l ant

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lamm

atory

dru

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O te

mpo

raril

y reli

eves

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or ac

hes a

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ains d

ue to

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min

or p

ain o

f arth

ritis O

mus

cular

ache

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bac

kach

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men

stru

al cr

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hea

dach

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toot

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omm

on co

ldO

tem

pora

rily r

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lerg

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c rea

ctio

n, es

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le a l

ergi

c to

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rin. S

ympt

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ay in

clude

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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

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aller

gic r

eact

ion

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rs, s

top

use a

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xen,

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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

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ents

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M ES

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AL

ab

eli

ng

Fo

rma

t In

form

ati

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lin

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Reference ID: 4601010

Page 18: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

160 CAPSULES

Actual Size

160 CAPSULES

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s

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)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

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e tha

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ver g

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n Co

ntro

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ter r

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ctio

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drin

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rote

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rnin

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rton.

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tive

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e #1,

gela

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lycer

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nito

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arm

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thyle

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lycol

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idon

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opyle

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lycol

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ified

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orbi

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sorb

itol

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ke 1

caps

ule e

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mpt

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psul

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- to

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erio

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ules

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erio

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adul

ts an

dch

ildre

n12

year

s and

olde

r:

child

ren

unde

r12

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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

:

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nts

: Hel

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ub

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ex

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6pt

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g F

ac

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ontin

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: 7p

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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

Page 19: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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Naproxen Sodium Capsules, 220 mg (NSAID)

St ng h to la t 12 h urs

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Pain R lie e F v r R d cer

Nap ox n Sodi m C psules, 2 0 mg (NSAI )

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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

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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

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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

Page 20: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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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 &

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Pp u sSa s es6

0 a u sS8 C p u sU

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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

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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

Page 21: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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

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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

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Reference ID: 4601010

Page 22: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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

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he o

wner

s of A

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® L

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Man

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600

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d,Pr

ince

ton,

NJ

0854

0

L000

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R02

20

Lot/E

XP

R 0.1250"

Hinge/NV Area Back 1.0000"

2.37

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Drug

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Ask a

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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

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Reference ID: 4601010

Page 23: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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***compare to the active ingredient in ALEVE® Liquid Gels

pain reliever/fever reducer

strength to last 12 hours

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naproxen sodium capsules, 220 mg (NSAID)

naproxen sodium capsules, 220 mg (NSAID)

napr

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sodi

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20 m

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SAID

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BIO

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AL

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Reference ID: 4601010

Page 24: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

Lot/E

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L000

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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

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**liquid-fill d capsule

55”

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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

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ing ap

plies

to yo

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leg s

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pain

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0 day

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If pr

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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

Page 25: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

Lot/E

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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 **

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to last 12 hourshh

55”

1880 cac psules** **liquid-filled capsule

strengt

pain reliever/fever reducer

naproxen sodiumcapsules, 220 mg(NSAID)

6.25”

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Drug

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ve in

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man

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purif

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mm

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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

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ery 8

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s whil

e sym

ptom

s las

tO

for t

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st do

se yo

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odO

do no

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eed 3

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ules i

n a 24

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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

Page 26: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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

Page 27: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

.

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

Page 28: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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

Page 29: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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

Page 30: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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

Page 31: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

.

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

Page 32: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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

Page 33: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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

Page 34: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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

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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”

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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

Page 35: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

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

Page 36: Naproxen Sodium capsule · 12 hours while symptoms last Ofor 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

--------------------------------------------------------------------------------------------

--------------------------------------------------------------------------------------------

------------------------------------------------------------

(

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