5
® ® naproxen sodium tablets, 220 mg (NSAID) Pain reliever/fever reducer naproxen sodium tablets, 220 mg (NSAID) Pain reliever/fever reducer ® ® STRENGTH TO L12 HOURS ARTHRITIS CAP Easy Open 225 FREE FREE TABLETS TABLETS PURCHASE WITH THIS PURCHASE WITH THIS 25 25 ® ® naproxen sodium tablets, 220 mg (NSAID) Pain reliever/fever reducer naproxen sodium tablets, 220 mg (NSAID) Pain reliever/fever reducer ® ® TABLETS STRENGTH TO LAST 12 HOURS ARTHRITIS CAP Easy Open PACKAGE NOT CHILD-RESISTANT PACKAGE NOT CHILD-RESISTANT 00000000 225 FREE FREE TABLETS TABLETS PURCHASE WITH THIS PURCHASE WITH THIS 25 25 FDA00079-3 Reference ID: 4466381

Easy Open ARTHRITIS CAP 25 - accessdata.fda.gov · It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so

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Page 1: Easy Open ARTHRITIS CAP 25 - accessdata.fda.gov · It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so

®®

naproxen sodium tablets, 220 mg (NSAID) Pain reliever/fever reducernaproxen sodium tablets, 220 mg (NSAID) Pain reliever/fever reducer

®®

200 TABLETS

STRENGTH TO LAST

12 HOURS

ARTHRITIS CAPEasy Open

PACKAGE NOT CHILD-RESISTANTPACKAGE NOT CHILD-RESISTANT

00000000

225FREEFREETABLETSTABLETS

PURCHASEWITH THISPURCHASEWITH THIS

2525

®®

naproxen sodium tablets, 220 mg (NSAID) Pain reliever/fever reducernaproxen sodium tablets, 220 mg (NSAID) Pain reliever/fever reducer

®®

200 TABLETS

STRENGTH TO LAST

12 HOURS

ARTHRITIS CAPEasy Open

PACKAGE NOT CHILD-RESISTANTPACKAGE NOT CHILD-RESISTANT

00000000

225FREEFREETABLETSTABLETS

PURCHASEWITH THISPURCHASEWITH THIS

2525

FDA00079-3

Reference ID: 4466381

Page 2: Easy Open ARTHRITIS CAP 25 - accessdata.fda.gov · It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so

Do not use this product if printed safety seal bearing "Bayer HealthCare" under cap is torn or missing.

LOPEN TO READ DRUG FACTSBEFORE USE

oe

)

Napr

oxen

sodiu

m22

0 m

g(n

apro

xen

200

mg)

(N

SAID

)*....

......

......

..Pain

reiev

er/

fev

er re

duce

r*n

onste

roida

lan

ti-inf

lamm

ator

y dru

g

Drug

Fac

ts

Drug

Fac

ts (c

ontin

ued)

Drug

Fac

ts (c

ontin

ued)

• tem

pora

rily

relie

ves

min

or a

ches

and

pai

ns d

ue to

:

• min

or p

ain

of a

rthrit

is • m

uscu

lar a

ches

• bac

kach

e • m

enst

rual

cra

mps

• hea

dach

e • t

ooth

ache

• the

com

mon

col

d

• tem

pora

rily

redu

ces

feve

r

sA

ry

art

Nap

roxe

n so

dium

may

cau

se a

sev

ere

alle

rgic

reac

tion,

esp

ecia

lly in

peo

ple

alle

rgic

to a

spiri

n. S

ympt

oms

may

in

clude

:

• hive

s • f

acia

l swe

lling

• ast

hma

(whe

ezin

g)

• sho

ck

• skin

redd

enin

g • r

ash

• blis

ters

If an

alle

rgic

reac

tion

occu

rs, s

top

use

and

seek

med

ical h

elp

right

awa

y.St

omac

h bl

eedi

ng w

arni

ng: T

his

prod

uct c

onta

ins

an N

SAID

, wh

ich m

ay c

ause

sev

ere

stom

ach

blee

ding

. Th

e ch

ance

is

high

er if

you

:

• are

age

60

or o

lder

• hav

e ha

d st

omac

h ul

cers

or b

leed

ing

prob

lem

s

• tak

e a

bloo

d th

inni

ng (a

ntico

agul

ant)

or s

tero

id d

rug

• tak

e ot

her d

rugs

con

tain

ing

pres

crip

tion

or n

onpr

escr

iptio

n NS

AIDs

(asp

irin,

ibup

rofe

n, n

apro

xen,

or o

ther

s)

• hav

e 3

or m

ore

alco

holic

drin

ks e

very

day

whi

le u

sing

this

prod

uct

• tak

e m

ore

or fo

r a lo

nger

tim

e th

an d

irect

edHe

art a

ttack

and

stro

ke w

arni

ng: N

SAID

s, e

xcep

t asp

irin,

in

crea

se th

e ris

k of

hea

rt at

tack

, hea

rt fa

ilure

, and

stro

ke. T

hese

ca

n be

fata

l. Th

e ris

k is

high

er if

you

use

mor

e th

an d

irect

ed o

r for

lo

nger

than

dire

cted

.

nt u

• if y

ou h

ave

ever

had

an

alle

rgic

reac

tion

to a

ny o

ther

pai

n re

lieve

r/fev

er re

duce

r

• rig

ht b

efor

e or

afte

r hea

rt su

rger

y

Ak

a t

r f

r u

f

• the

sto

mac

h ble

edin

g wa

rnin

g ap

plie

s to

you

• you

hav

e a

hist

ory

of s

tom

ach

prob

lem

s, su

ch a

s he

artb

urn

• you

hav

e hi

gh b

lood

pre

ssur

e, h

eart

dise

ase,

liver

cirr

hosis

, kid

ney

dise

ase,

ast

hma,

or h

ad a

stro

ke

• you

are

takin

g a

diur

etic

• you

hav

e pr

oble

ms

or s

erio

us s

ide

effe

cts

from

takin

g pa

in

relie

vers

or f

ever

redu

cers

Ak

a t

r r p

ara

t f

r u

f y

u ar

• und

er a

doc

tor's

car

e fo

r any

ser

ious

con

ditio

n

• tak

ing

any

othe

r dru

g

n

s

• tak

e wi

th fo

od o

r milk

if s

tom

ach

upse

t occ

urs

e

d s

• you

exp

erie

nce

any

of th

e fo

llowi

ng s

igns

of s

tom

ach

bleed

ing:

• fee

l fain

t • v

omit

blood

• h

ave

blood

y or

bla

ck s

tool

s

• hav

e st

omac

h pa

in th

at d

oes

not g

et b

ette

r

• you

hav

e sy

mpt

oms

of h

eart

prob

lem

s or

stro

ke:

• che

st p

ain

• t

roub

le b

reat

hing

• wea

knes

s in

one

par

t or s

ide

of b

ody

• slu

rred

spee

ch

• leg

swel

ling

• pai

n ge

ts w

orse

or l

asts

mor

e th

an 1

0 da

ys

• fev

er g

ets

wors

e or

last

s m

ore

than

3 d

ays

• you

hav

e di

fficu

lty sw

allow

ing

• it f

eels

like

the

pill i

s st

uck

in yo

ur th

roat

• red

ness

or s

wellin

g is

pres

ent i

n th

e pa

infu

l are

a

• any

new

sym

ptom

s ap

pear

a

sn

ask

a h

ealth

pro

fess

iona

l bef

ore

use.

It is

esp

ecia

lly im

porta

nt n

ot to

use

nap

roxe

n so

dium

dur

ing

the

last

3 m

onth

s of

pre

gnan

cy u

nles

s de

finite

ly di

rect

ed to

do

so

by a

doc

tor b

ecau

se it

may

cau

se p

roble

ms

in th

e un

born

chi

ld o

r co

mpl

icatio

ns d

urin

g de

liver

y.Ke

ep o

ut o

f rea

ch o

f chi

ldre

n. I

n ca

se o

f ove

rdos

e, g

et m

edica

l he

lp o

r con

tact

a P

oiso

n Co

ntro

l Cen

ter r

ight

awa

y.

D •

e n

• e

ve

de

e

e

• drin

k a

full g

lass

of w

ater

with

eac

h do

se

Adul

ts a

nd c

hild

ren

• ta

ke 1

tabl

et e

very

8 to

12

hour

s 12

yea

rs a

nd o

lder

wh

ile s

ympt

oms

last

• fo

r the

firs

t dos

e yo

u m

ay ta

ke

2 ta

blet

s wi

thin

the

first

hou

r

• d

o no

t exc

eed

2 ta

blet

s in

any

8- t

o

12

-hou

r per

iod

• d

o no

t exc

eed

3 ta

blet

s in

a 2

4-ho

ur

pe

riod

Child

ren

unde

r 12

year

s •

ask

a d

octo

r

Oe

o

• eac

h ta

blet

con

tain

s: s

odiu

m 2

0 m

g

• sto

re a

t 20-

25°C

(68-

77°F

). A

void

hig

h hu

mid

ity a

nd e

xces

sive

heat

abo

ve 4

0°C

(104

°F).

F

D&C

blue

#2 la

ke, h

ypro

mel

lose

, m

agne

sium

ste

arat

e, m

icroc

ryst

allin

e ce

llulo

se, p

olye

thyle

ne

glyc

ol, p

ovid

one,

talc,

tita

nium

diox

ide

o

os

9

(

Dist. by:Bayer HealthCare LLCWhippany, NJ 07981

Bayer, the Bayer Cross, Aleve andAll Day Strong are registeredtrademarks of Bayer.

XXXXXXXX

Reference ID: 4466381

(b) (4)

Page 3: Easy Open ARTHRITIS CAP 25 - accessdata.fda.gov · It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so

'11

~ 0

~ t'\ = a fl) ii:i• ~ ..... 0 0 ~ ~ .. ----·

L

SAVE s1.00 on any one (1) Aleve®. Aleve® Back & Muscle Pain.

or Aleve® Liquid Gels 80ct or larger CD ..... ER: LIMIT Dll: COUPON PBI PURCHAIE on spec Wied product(•). •Ill(•) and quantity slalld. Ll'l11T GF 4 EXAl:T MME CGUPGll PER HGUIEHllJl PER DAY. You poy any-tox. Void H copied, ..id, tran,,.rlld, ollo!Jd. or ouctiollod. RETAllBI: You ore llltho~zed to lit 11 our agent 1nd redeem this coupon at llce valut on tho s1111clll1d product(s). Wo wtll 11lmbu111 you for th• flC8 val111 of this coupo• plus B• H submitted io complianoe- tho Bl)lr HHilhCI"' U.C Coupon Redemption Palley, lncorporat!d hnln by rer...nce. UBE Niil CDlllllTBIT WITH lltEIE 'IERMI MAY CONmM'E IRAUD AllD MAY VDID AU. COUPONS IUHITlH. Sond coupo• to: illrjar HllllthCorJ U.C 1356, P.O. Bax 880001, E Plso, TX 1185111HXD1. CUhVllue, 1!.!0th o11J. Good onlylntlle LI.SA

1-I L ______________________________ _

L _____________________________ _

Reference ID

: 4466381

Page 4: Easy Open ARTHRITIS CAP 25 - accessdata.fda.gov · It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so

~ t'\ = a fl) ii:i• ~

o C) 'll l!JQ ~ ~

L

SAVE s2.00 on any one (1) Aleve®. Aleve® Back & Muscle Pain.

or Aleve® Liquid Gels 80ct or larger CD ..... ER: LIMIT Dll: COUPON PBI PURCHAIE on spec Wied product(•). •Ill(•) and quantity slalld. Ll'l11T GF 4 EXAl:T UME CGUPGll PER HGUIEHllJl PER DAY. You poy any-tox. Void H copied, ..id, tran,,.rlld, ollo!Jd. or ouctiollod. RETAllBI: You ore llltho~zed 111 lit 11 our agent 1nd redeem 11111 coupon at llce valut on tho s1111clll1d product(s). Wo wtll 11lmbu111 yoo for 1111 flC8 val111 of 1111s coupo• plus B• H submitted io complianoe- tho Bl)lr HHllhC.11 U.C Coupon Redemption Palley, lncorporat!d hnln by rer...nce. UBE Niil CDlllllTBIT WITH lltEIE 'IERMI MAY CONmM'E IRAUD AllD MAY VDID AU. COUPONS IUHITlH. Sond coupo .. 111: illrJar HllllthCorJ u.c 1356, P.O. Bax 880001, E Plso, TX 1185111HXD1. CUhVllue, 1"!01h o11J. Good onlylntlle LI.SA

1-I L ______________________________ _

L _____________________________ _

Reference ID

: 4466381

Page 5: Easy Open ARTHRITIS CAP 25 - accessdata.fda.gov · It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so

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

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(

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/

KAREN M MAHONEY 07/23/2019 11:58:45 AM

Reference ID: 4466381