for temporary relief of minor back and muscle aches and painsfor temporary relief of minor back and muscle aches and painsfor temporary relief of minor back and muscle aches and painsfor temporary relief of minor back and muscle aches and painsfor temporary relief of minor back and muscle aches and pains
naproxen sodium tablets, 220 mg (NSAID)Pain reliever/fever reducer naproxen sodium tablets, 220 mg (NSAID)
Pain reliever/fever reducer
BACK & MUSCLE PAIN
®®
Drug
Fac
tsAc
tive
ingr
edie
nt
Purp
oses
( in e
ach
tabl
et)
Napr
oxen
sodiu
m 2
20 m
g (n
apro
xen
200
mg)
(NSA
ID)*
......
Pain
relie
ver/
feve
r red
ucer
*non
stero
idal a
nti-in
flam
mat
ory d
rug
Uses
• t
empo
rarily
relie
ves m
inor a
ches
and
pain
s du
e to
: • b
acka
che
• mus
cular
ach
es
• mino
r pain
of a
rthrit
is • m
enstr
ual c
ram
ps • h
eada
che
• too
thac
he • t
he co
mm
on co
ld
• tem
pora
rily re
duce
s fev
er
War
ning
sAl
lerg
y al
ert:
Napr
oxen
sodiu
m m
ay ca
use
a se
vere
alle
rgic
reac
tion,
esp
ecial
ly in
peop
le all
ergic
to a
spirin
. Sy
mpt
oms m
ay in
clude
: • h
ives • f
acial
swel
ing • a
sthm
a (w
heez
ing) • s
hock
• skin
redd
ening
• ras
h • b
lister
s If a
n alle
rgic
reac
tion o
ccurs,
sto
p use
and s
eek m
edica
l help
right
away
.St
omac
h blee
ding w
arning
: This
prod
uct
conta
ins an
NSA
ID, w
hich m
ay ca
use s
evere
sto
mach
blee
ding.
The c
hanc
e is h
igher
if you
: • a
re ag
e 60 o
r olde
r • h
ave h
ad st
omac
h ulc
ers or
blee
ding p
roblem
s • ta
ke a
blood
thi
nning
(anti
coag
ulant)
or st
eroid
drug
• take
othe
r drug
s con
tainin
g pres
cripti
on or
no
npres
cripti
on N
SAID
s (as
pirin,
ibup
rofen
, na
proxe
n, or
others
) • h
ave 3
or m
ore
alcoh
olic d
rinks
every
day w
hile u
sing t
his
produ
ct • ta
ke m
ore or
for a
long
er tim
e th
an d
irecte
d
Drug
Fac
ts (c
ontin
ued)
Heart
attac
k and
stro
ke w
arning
: NSA
IDs,
exce
pt as
pirin,
inc
rease
the r
isk of
heart
attac
k, he
art fa
ilure,
and s
troke
. The
se
can b
e fata
l. The
risk i
s high
er if y
ou us
e more
than
direc
ted or
for
long
er tha
n dire
cted.
Do n
ot u
se • if
you h
ave e
ver h
ad an
aller
gic re
actio
n to
any o
ther p
ain re
leve
r/feve
r redu
cer •
rgh
t befo
re or
after
heart
surge
ryAs
k a
doct
or b
efor
e us
e if • th
e stom
ach b
leedin
g warn
ing
appli
es to
you • y
ou ha
ve a
histor
y of s
tomac
h prob
lems,
such
as
heart
burn
• you
have
high
bloo
d pres
sure,
heart
dise
ase,
liver c
irrhos
is, ki
dney
dise
ase,
asthm
a, or
had a
strok
e • y
ou
are ta
king a
diure
tic • y
ou ha
ve pr
oblem
s or s
eriou
s side
eff
ects
from
takng
pan r
eliev
ers or
feve
r redu
cers
Ask
a do
ctor
or p
harm
acis
t bef
ore
use
if yo
u ar
e • u
nder
a do
ctor's
care
for an
y seri
ous c
ondit
ion • ta
king a
ny ot
her d
rugW
hen
usin
g th
is p
rodu
ct • ta
ke w
ith fo
od or
milk
if stom
ach
upse
t occ
ursSt
op u
se a
nd a
sk a
doc
tor i
f• y
ou ex
perie
nce a
ny of
the f
ollow
ing si
gns o
f stom
ach b
leedin
g:• fe
el fai
nt • v
omit b
lood • h
ave b
loody
or bl
ack s
tools
• hav
e stom
ach p
ain th
at do
es no
t get
bette
r• y
ou ha
ve sy
mptom
s of h
eart p
roblem
s or s
troke
:• c
hest
pain
• trou
ble br
eathi
ng• w
eakn
ess i
n one
part o
r side
of bo
dy• s
lurred
spee
ch • le
g swe
lling
• pain
gets
worse
or la
sts m
ore th
an 10
days
• feve
r gets
wo
rse or
lasts
more
than
3 da
ys • y
ou ha
ve di
fficult
y sw
allow
ing • it
feels
like t
he pi
ll is st
uck i
n you
r throa
t • re
dnes
s or s
wellin
g is p
resen
t in th
e pain
ful ar
ea
• any
new
symp
toms a
ppea
rIf
preg
nant
or b
reas
t-fee
ding
, ask
a he
alth p
rofes
siona
l befo
re us
e. It
is es
pecia
lly im
porta
nt no
t to us
e nap
roxen
sodiu
m du
ring t
he la
st 3 m
onths
of pr
egna
ncy u
nless
defin
itely
direc
ted
to do
so by
a do
ctor b
ecau
se it
may c
ause
prob
lems i
n the
Dru
g Fa
cts (
conti
nued
)un
born
child
or co
mplica
tions
durin
g deli
very.
Keep
out o
f rea
ch of
child
ren. I
n cas
e of
overd
ose,
get m
edica
l help
or co
ntact
a Po
ison C
ontro
l Cen
ter rg
ht aw
ay.
Dire
ctio
ns • d
o no
t tak
e m
ore
than
di
rect
ed • t
he s
mal
lest
effe
ctiv
e do
se
shou
ld b
e us
ed • d
rink a
full g
lass o
f wa
ter w
ith e
ach
dose
Adult
s and
• ta
ke 1
tablet
every
8 to
12
child
ren 12
hours
whil
e sym
ptoms
last
years
and
• for th
e frst
dose
you m
ay
older
tak
e 2 ta
blets
within
the
first h
our
• d
o not
exce
ed 2
tablet
s in
any 8
- to 12
-hour
pero
d
• do n
ot ex
ceed
3 tab
lets i
n a
24
-hour
perio
dCh
ildren
• a
sk a
docto
run
der 1
2 ye
ars
Othe
r inf
orm
atio
n • e
ach t
ablet
co
ntains
: sod
ium 20
mg • s
tore a
t 20
-25°C
(68-7
7°F).
Avoid
high
humi
dity a
nd
exce
ssive
heat
abov
e 40°C
(104
°F).
Inac
tive
ingr
edie
nts
FD&C
blue
#2
lake,
hy
prom
ellos
e, m
agne
sium
stea
rate
, m
icroc
rysta
lline
cellu
lose,
poly
ethy
lene
glyco
l, pov
idone
, talc
, tita
nium
diox
ide
Ques
tions
or c
omm
ents
?
1-80
0-39
5-06
89 (M
on-F
ri 9A
M –
5PM
EST
)
Dist
. by:
Baye
r Hea
lthCa
re L
LCW
hipp
any,
NJ 0
7981
Safe
ty S
quea
se is
a re
gist
ered
tra
dem
ark
of T
he P
roct
er &
Gam
ble
Com
pany
. Use
d wi
th p
erm
issi
on.
Bayer, the Bayer Cross, Aleve and All Day Strongare registered tradem
arks of Bayer.
0000
XX
XX
XX
XX
Lot
Exp
Mad
e in
Reference ID: 4139605Reference ID: 4142543
(b) (4)
-
-
-
4.5 pt
4.5 pt
4.5 pt
4 pt
4.75 pt
>39
LIFT
HEREXXXXXXXX
other drugs containing
prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoho ic drinks every day while using this product • take more or for a longer time than
directed. Heart attack and stroke warning: NSAIDs, except asprin, 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. Do not use f you have ever
had an allergic reaction to any o her pain re iever/fever reducer. Ask a doctor or pharmacist before use if you are taking
any other drug. Stop use and ask a doctor if you experience any of the fo lowing signs of stomach bleeding (feel faint, vom t blood, have bloody or black stools, have stomach pain that does not get
be ter), have symptoms of heart problems or stroke (chest pain, trouble
breathing, weakness in one part or side of body, slurred speech, leg swelling), or if pain or fever gets worse. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Directions Adults and children 12 years and older: take 1 tablet with water every 8 to 12 hours while symptoms last. For the first dose you may take 2 tablets within the first hour. Do not exceed 3 tablets in a 24-hour period. Ch ldren under 12 years: ask a doctor. Questions or comments? 1-800-395-0689 (Mon-Fri 9AM – 5PM EST)Dist. by: Bayer HealthCare LLC, Whippany, NJ 07981
Do not use f foil sealimprinted with "SAFETY SQUEASE"
on bottle opening is missing or broken.See Carton For Full Information Warnings Allergy alert:
Naproxen sodium may cause a severe allergic reaction, especially in people a lergic to aspirin. Symptoms may include: hives,
facial swel ing, asthma (wheezing), shock, skin reddening, rash, or b isters. If an a lergic reaction occurs, stop use and seek medical help right
away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher f you: • are age 60 or older • have had stomach ulcers
or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take
Reference ID: 4139605Reference ID: 4142543
(b) (4)
Dist. b
y:Ba
yer H
ealth
Care
LLC
Whipp
any,
NJ 07
981
Safe
ty Sq
ueas
e is a
regi
stere
dtra
dem
ark o
f The
Pro
cter &
Gam
ble
Com
pany
. Use
d with
perm
issio
n.Ba
yer,
the Ba
yer C
ross,
Aleve
and A
ll Day
Stron
g are
regist
ered t
radem
arks o
f Bay
er.Lo
tE
xp
M
ade
in
XXXXXXXX
Drug FactsActive ingredient Purposes(in each tablet )Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*......Pain reliever/
fever reducer*nonsteroidal anti-inflammatory drug
Uses• temporarily relieves minor aches and
pains due to:• backache
• menstrual cramps • muscular aches
• toothache • minor pain of arthritis • headache • the common cold
• temporarily reduces fever
Warnings
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:• hives
• facial swelling• asthma (wheezing)
• shock• skin reddening
• rash• blistersIf 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:• are age 60 or older• have had stomach ulcers or bleeding
problems• take a blood thinning (anticoagulant) or
steroid drug• take other drugs containing prescrption
or nonprescription NSAIDs (aspirn, ibuprofen, naproxen, or others)
Drug Facts (continued)• have 3 or more alcoholc drinks every day while using this product• take more or for a longer time than drectedHeart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is hgher if you use more than directed or for longer than directed. Do not use• if you have ever had an allergic reaction to any other pain
reliever/fever reducer• right before or after heart surgeryAsk a doctor before use if• the stomach bleeding warning applies to you• you have a history of stomach problems, such as heartburn• you have high blood pressure, heart disease, liver cirrhosis,
kidney disease, asthma, or had a stroke• you are taking a diuretic• you have problems or serious side effects from taking pain
relievers or fever reducersAsk a doctor or pharm
acist before use if you are• under a doctor's care for any serious condition• taking any other drugW
hen using this product• take with food or m
lk if stomach upset occursStop use and ask a doctor if• you experience any of the following sgns of stomach bleeding:• feel faint • vomit blood• have bloody or black stools• have stomach pain that does not get better
• you have symptoms of heart problems or stroke:• chest pain • trouble breathing• weakness in one part or side of body• slurred speech • leg swelling
• pain gets worse or lasts more than 10 days• fever gets worse or lasts more than 3 days• you have difficulty swallowing• it feels like the pill is stuck in your throat• redness or swelling is present n the painful area• any new symptoms appear
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 chld 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• do not take more than directed• the smallest effective dose should be used• drink a full glass of water with each doseAdults and • take 1 tablet every 8 to 12children 12 hours while symptoms lastyears and • for the first dose you may older take 2 tablets wthin the first hour • do not exceed 2 tablets in any 8- to 12-hour period • do not exceed 3 tablets in a 24-hour perodChildren under • ask a doctor12 years
Other information
• each tablet contains: sodium 20 mg• store at 20-25°C (68-77°F). Avoid high
humidity and excessive heat above 40°C (104°F).
Inactive ingredients FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
Drug Facts (continued)Questions or com
ments? 1-800-395-0689
(Mon-Fri 9AM
– 5PM EST)
0000
naproxen sodium tablets, 220 mg (NSAID)Pain reliever/fever reducer naproxen sodium tablets, 220 mg (NSAID)
Pain reliever/fever reducer for temporary relief of minor back and muscle aches and painsfor temporary relief of minor back and muscle aches and painsfor temporary relief of minor back and muscle aches and painsfor temporary relief of minor back and muscle aches and painsfor temporary relief of minor back and muscle aches and pains
BACK & MUSCLE PAIN
Reference ID: 4139605Reference ID: 4142543
(b) (4)
-
-
-
4.5 pt
4.5 pt
4.5 pt
4 pt
4.75 pt
>39
LIFT
HEREXXXXXXXX
other drugs containing
prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoho ic drinks every day while using this product • take more or for a longer time than
directed. Heart attack and stroke warning: NSAIDs, except asprin, 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. Do not use f you have ever
had an allergic reaction to any o her pain re iever/fever reducer. Ask a doctor or pharmacist before use if you are taking
any other drug. Stop use and ask a doctor if you experience any of the fo lowing signs of stomach bleeding (feel faint, vom t blood, have bloody or black stools, have stomach pain that does not get
be ter), have symptoms of heart problems or stroke (chest pain, trouble
breathing, weakness in one part or side of body, slurred speech, leg swelling), or if pain or fever gets worse. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Directions Adults and children 12 years and older: take 1 tablet with water every 8 to 12 hours while symptoms last. For the first dose you may take 2 tablets within the first hour. Do not exceed 3 tablets in a 24-hour period. Ch ldren under 12 years: ask a doctor. Questions or comments? 1-800-395-0689 (Mon-Fri 9AM – 5PM EST)Dist. by: Bayer HealthCare LLC, Whippany, NJ 07981
Do not use f foil sealimprinted with "SAFETY SQUEASE"
on bottle opening is missing or broken.See Carton For Full Information Warnings Allergy alert:
Naproxen sodium may cause a severe allergic reaction, especially in people a lergic to aspirin. Symptoms may include: hives,
facial swel ing, asthma (wheezing), shock, skin reddening, rash, or b isters. If an a lergic reaction occurs, stop use and seek medical help right
away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher f you: • are age 60 or older • have had stomach ulcers
or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take
Reference ID: 4139605Reference ID: 4142543
(b) (4)
for temporary relief of minor back and muscle aches and painsfor temporary relief of minor back and muscle aches and painsfor temporary relief of minor back and muscle aches and painsfor temporary relief of minor back and muscle aches and painsfor temporary relief of minor back and muscle aches and pains
naproxen sodium tablets, 220 mg (NSAID)Pain reliever/fever reducer
BACK & MUSCLE PAIN
Reference ID: 4139605Reference ID: 4142543
(b) (4)
-
-
-
4.5 pt
4.5 pt
4.5 pt
4.5 pt
5.0 pt
>39
XXXXXXXX
See Carton for Full Information Warnings
Allergy alert: Naproxen sodium may cause a severe allergic reac ion which may include: hives, facial
swe ling, asthma (wheezing) or shock. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory
drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: • are age 60 or older • have had stomach ulcers or
bleeding problems • take a blood thinning (an icoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs
(aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed.
Heart attack and stroke warning: NSAIDs, 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. Do not use if you have ever had an allergic reac ion to any other pain re iever/fever reducer. Stop use and ask a doctor if you experience any of the following signs of stomach bleeding (feel faint, vom t blood, have bloody or black stools, have stomach pain that does not get better), have symptoms of heart problems or stroke (chest pain, trouble breathing, weakness in one part or side of body, slurred speech, leg swelling), or f pain or fever gets worse. If pregnant or breast-feeding, ask a hea th professional before use. Directions Adults and ch ldren 12 years and older: take 1 tablet with water every 8 to 12 hours while symptoms last. For the first dose you may take 2 tablets within the first hour. Do not exceed 3 tablets in a 24-hour period. Children under 12 years: ask a doctor. Questions
or comments? 1-800-395-0689 (Mon-Fri 9AM – 5PM EST)Dist. by: Bayer HealthCare LLCWhippany, NJ 07981
Reference ID: 4139605Reference ID: 4142543
(b) (4)
---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------/s/----------------------------------------------------
KAREN M MAHONEY08/22/2017
Reference ID: 4142543