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

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)

'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

~ 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

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

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

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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