® ® STRENGTH TO LAST 12 HOURS 24 TABLETS For temporary relief of headache pain naproxen sodium tablets, 220 mg (NSAID) Pain reliever/fever reducer Drug Facts Active 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: • headache • minor pain of arthritis • muscular aches • backache • menstrual cramps • toothache • 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 • 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: • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) 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 Drug Facts (continued) • 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 • if you have ever had an allergic reaction toany other pain reliever/fever reducer • right before or after heart surgery Ask 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 reducers Ask a doctor or pharmacist before use if you are • under a doctor's care for any serious condition • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin • taking any other drug When using this product • take with food or milk if stomach upset occurs Stop use and ask a doctor if • you experience any of the following signs 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 in the painful area • any new symptoms appear 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 Drug Facts (continued) 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 • do not take more than directed • the smallest effective dose should be used • drink a full glass of water with each dose Adults and • take 1 tablet every 8 to 12 children 12 hours while symptoms last years and • for the first dose you may older take 2 tablets within the first hour • do not exceed 2 tablets in any 8- to 12-hour period • do not exceed 3 tablets in a 24-hour period Children • ask a doctor under 12 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 Questions or comments? 1-800-395-0689 (Mon-Fri 9AM – 5PM EST) Dist. by: Bayer HealthCare LLC Whippany, NJ 07981 Bayer, the Bayer Cross, Aleve and All Day Strong are registered trademarks of Bayer. 0000 00000000 Lot Exp Made in Do not use if carton is open or if foil seal imprinted with "Bayer HealthCare" on bottle opening is missing or broken. Drug Facts Title Drug Facts Continued Headings* Subheadings Body Text Bullets Leading Hairlines Box and Barlines † Characters Per Inch: >7.0 pt 7 pt 7 pt-bold italic* ≥6 pt ≥6 pt 5 pt ≥0 pt 0.5 pt rule >0.5 pt rule No more than 39 CATEGORY REQUIRED ACTUAL IN FILE * Headings are to be at least 2pts larger than Body Text ** Drug Facts Title to be larger than all other type size used in DFP † Box Barline may be omitted and color contrast used to hightlight Drug Facts Info 7.1 pt 7 pt 7 pt 6 pt 6 pt 12 pt 0 pt 0.5 pt 2.5 pt ≤39 DRUG FACTS INFO: (Modified Format – updated 5/18/18) FDA00232-4 Reference ID: 4605630
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For temporary relief of headache pain 24 · HEADACHE PAIN Pain reliever/fever reducer STRENGTH TOLAST 12HOURS For temporary relief of headache pain 50 TABLETS Drug Facts Title Drug
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®®
STR
ENG
THTO
LAST
12H
OU
RS
24
TAB
LETS
For
tem
pora
ry r
elie
fof
hea
dach
e pa
in
napro
xen s
odium
table
ts, 22
0 mg(
NSAI
D)Pa
in rel
iever/
fever
reduce
r
Drug
Fact
sAc
tive
ingr
edie
nt
P
urpo
ses
( in e
ach
tabl
et)
Napr
oxen
sodiu
m 2
20 m
g(n
apro
xen
200
mg)
(NSA
ID)*.
.......P
ain re
lieve
r/
fever
redu
cer
*non
stero
idal a
nti-in
flam
mat
ory d
rug
Uses • tem
pora
rily re
lieve
s mino
r ach
es a
nd p
ains
due
to:
• h
eada
che
• m
inor p
ainof
arth
ritis
• m
uscu
lar a
ches
• bac
kach
e
• men
strua
l cra
mps
• too
thac
he
• t
he co
mm
on co
ld • t
empo
rarily
redu
ces f
ever
War
ning
sAl
lerg
y al
ert:
Napr
oxen
sodiu
m m
ay ca
use
ase
vere
alle
rgic
reac
tion,
esp
ecial
ly in
peop
leall
ergic
to a
spirin
. Sym
ptom
s may
inclu
de:
• hive
s • fa
cial s
wellin
g
• asth
ma
(whe
ezing
) • s
hock
• s
kin re
dden
ing• r
ash
• b
lister
sIf a
n all
ergic
reac
tion
occu
rs, st
op u
se a
nd se
ekm
edica
l help
righ
t awa
y.St
omac
h bl
eedi
ng w
arni
ng: T
hispr
oduc
tco
ntain
s an
NSAI
D, w
hich
may
caus
e se
vere
stom
ach
bleed
ing. T
he ch
ance
is h
igher
if yo
u:• a
re a
ge 6
0 or
olde
r • h
ave
had
stom
ach
ulcer
s or b
leedin
g pr
oblem
s
• tak
e a
blood
thinn
ing (a
ntico
agula
nt) o
rste
roid
drug
• t
ake
othe
r dru
gs co
ntain
ingpr
escr
iption
or n
onpr
escr
iption
NSA
IDs
(asp
irin, ib
upro
fen,
nap
roxe
n, o
r oth
ers)
• hav
e 3
or m
ore
alcoh
olic d
rinks
eve
ry d
aywh
ile u
sing
this
prod
uct
Drug
Fact
s (co
ntinu
ed)
• tak
e m
ore
or fo
r a lo
nger
time
than
dire
cted
Hear
t atta
ck a
nd s
troke
war
ning
: NSA
IDs,
exce
pt a
spiri
n,inc
reas
e th
e ris
k of h
eart
atta
ck, h
eart
failu
re, a
nd st
roke
.The
seca
n be
fata
l.The
risk
is h
igher
if yo
u us
e m
ore
than
dire
cted
orfo
r lon
ger t
han
direc
ted.
Do n
ot u
se
• if
you
have
ever
had
an
aller
gic re
actio
n to
any
other
pain
reliev
er/fe
ver r
educ
er
• r
ight b
efore
or af
ter he
art s
urger
yAs
k a
doct
or b
efor
e us
e if
• t
he st
omac
h ble
eding
war
ning
appli
es to
you
• y
ou h
ave
a his
tory
of s
tom
ach
prob
lems,
such
as h
eartb
urn
• y
ou h
ave
high
blood
pre
ssur
e, h
eart
disea
se, li
ver c
irrho
sis, k
idney
dise
ase,
asth
ma,
or h
ad a
stro
ke
• y
ou a
re ta
king
a diu
retic
• y
ou h
ave
prob
lems o
r ser
ious
side
effec
ts fro
m ta
king
pain
relie
vers
or f
ever
redu
cers
Ask
a do
ctor
or p
harm
acis
t bef
ore
use
if yo
u ar
e
• und
er a
docto
r's ca
re fo
r any
serio
us co
nditio
n
• tak
ing a
spirin
for h
eart
attac
k or s
troke
, bec
ause
nap
roxe
n m
ay d
ecre
ase
this
bene
fit of
aspir
in
• tak
ing a
ny o
ther
dru
gW
hen
usin
g th
is p
rodu
ct
• t
ake
with
food
or m
ilk if
stom
ach
upse
t occ
urs
Stop
use
and
ask
a d
octo
r if
• you
exp
erien
ce a
ny o
f the
follo
wing
sign
s of s
tom
ach
bleed
ing:
• fe
el fa
int
• v
omit b
lood
• h
ave
blood
y or b
lack
stools
• h
ave
stom
ach
pain
that
doe
s not
get
bett
er• y
ou h
ave
sym
ptom
s of h
eart
prob
lems o
r stro
ke:
• che
st pa
in
• tro
uble
brea
thing
• w
eakn
ess i
n on
epa
rt or
side
of b
ody
• s
lurre
d sp
eech
• le
g sw
elling
• p
ain g
ets w
orse
or l
asts
mor
e th
an 10
day
s • fe
ver g
ets
wors
e or
lasts
mor
e th
an 3
day
s • y
ou h
ave
diffic
ulty
swall
owing
• it
feels
like
the
pill is
stuc
k in
your
thro
at• r
edne
ss o
r swe
lling
is pr
esen
t in th
e pa
inful
area
• any
new
sym
ptom
s app
ear
If pr
egna
nt o
r bre
ast-f
eedi
ng, a
sk a
hea
lth p
rofe
ssion
al be
fore
use.
It is
esp
ecial
ly im
porta
nt n
ot to
use
nap
roxe
n so
dium
durin
g th
e las
t 3 m
onth
s of p
regn
ancy
unle
ss d
efini
tely
direc
ted
Drug
Fact
s (co
ntinu
ed)
to d
o so
by a
doc
tor b
ecau
se it
may
caus
epr
oblem
s in
the
unbo
rn ch
ild o
r com
plica
tions
durin
g de
liver
y.Ke
ep o
ut o
f rea
ch o
f chi
ldre
n. I
n ca
se o
fov
erdo
se, g
et m
edica
l help
or c
onta
ct a
Poiso
n Co
ntro
l Cen
ter r
ight a
way.
Dire
ctio
ns
• d
o no
t tak
e m
ore
than
dire
cted
• t
he s
mal
lest
effe
ctive
dos
esh
ould
be
used
• d
rink a
full g
lass o
fwa
ter w
ith e
ach
dose
Adult
s and
• tak
e 1
table
t eve
ry 8
to 12
ch
ildre
n 12
hour
s whil
e sy
mpt
oms l
ast
year
s and
• for t
he fir
st do
se yo
u m
ay
older
take
2 ta
blets
with
in th
e
first h
our
• do
not e
xcee
d 2
table
ts in
any 8
- to
12-h
our p
eriod
• do
not e
xcee
d 3
table
ts in
a24
-hou
r per
iodCh
ildre
n• a
sk a
doc
tor
unde
r 12
year
s
Othe
r inf
orm
atio
n
• eac
h ta
blet
cont
ains
: sod
ium 2
0 m
g
• sto
re a
t20
-25°
C (6
8-77
°F).
Avoid
high
hum
idity
and
exce
ssive
hea
t abo
ve 4
0°C
(104
°F).
Inac
tive
ingr
edie
nts
FD&C
blue
#2
lake,
hypr
omell
ose,
mag
nesiu
m st
eara
te,m
icroc
rysta
lline
cellu
lose,
poly
ethy
lene
glyco
l,po
vidon
e, ta
lc, tit
anium
diox
ide
Ques
tions
or c
omm
ents
?1-8
00-3
95-0
689
(Mon
-Fri
9AM
– 5
PM E
ST)
Dist
. by:
Baye
r Hea
lthCa
re L
LCW
hipp
any,
NJ 0
7981
Baye
r, th
e Ba
yer C
ross
, Ale
ve a
nd A
ll Da
y St
rong
are
regi
ster
ed tr
adem
arks
of B
ayer
.
0000
00000000
Lot
Exp
Mad
e in
Do not use if carton is open or if foil seal im
printed with
"Bayer HealthCare" on bottle opening is m
issing or broken.
Drug Facts Title
Drug Facts Continued
Headings*
Subheadings
Body Text
Bullets
Leading
Hairlines
Box and Barlines†
Characters Per Inch:
>7.0 pt
7 pt
7 pt-bold italic*
≥6 pt
≥6 pt
5 pt
≥0 pt
0.5 pt rule
>0.5 pt rule
No more than 39
CATEGORY REQUIRED ACTUAL IN FILE
* Headings are to be at least 2pts larger than Body Text** Drug Facts Title to be larger than all other type size used in DFP† Box Barline may be omitted and color contrast used to hightlight
Drug Facts Info
7.1 pt
7 pt
7 pt
6 pt
6 pt
12 pt
0 pt
0.5 pt
2.5 pt
≤39
DRUG FACTS INFO: (Modified Format – updated 5/18/18)
Bayer, the Bayer Cross, Aleve and All Day Strongare registered trademarks of Bayer.
Do not use if carton is open or if foil seal im
printed with
"Bayer HealthCare" on bottle opening is m
issing or broken.
Lot
Exp
Mad
ein
Drug
Fact
sAc
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/
fever
redu
cer
*non
stero
idal a
nti-in
flam
mat
ory d
rug
Uses
• tem
pora
rily re
lieve
s mino
r ach
es a
ndpa
ins d
ue to
:• h
eada
che
• m
inor p
ain o
f arth
ritis
• mus
cular
ach
es• b
acka
che
• m
enstr
ual c
ram
ps
• t
ooth
ache
• t
he co
mmon
cold
• tem
pora
rily re
duce
s fev
er
War
ning
sAl
lerg
y al
ert:
Napr
oxen
sodiu
m m
ay ca
use
ase
vere
alle
rgic
reac
tion,
esp
ecial
l y in
peop
leall
ergic
to a
spirin
. Sym
ptom
s may
inclu
de:
• hive
s
•
facia
l swe
lling
• asth
ma
(whe
ezing
) • s
hock
• skin
redd
ening
• r
ash
• blis
ters
If an
alle
rgic
reac
tion
occu
rs, st
op u
se a
ndse
ek m
edica
l help
righ
t awa
y.St
omac
h bl
eedi
ng w
arni
ng: T
hispr
oduc
tco
ntain
s an
NSAI
D, w
hich
may
caus
e se
vere
stom
ach
bleed
ing. T
he ch
ance
is h
igher
if yo
u:• a
re a
ge 6
0 or
olde
r• h
ave
had
stom
ach
ulcer
s or b
leedin
gpr
oblem
s• t
ake
a blo
od th
inning
(ant
icoag
ulant
) or
stero
id dr
ug• t
ake
othe
r dru
gs co
ntain
ing p
resc
riptio
nor
non
pres
cript
ion N
SAID
s (as
pirin,
ibupr
ofen
, nap
roxe
n, o
r oth
ers)
• hav
e 3 or
mor
e alco
holic
drink
s eve
ry da
ywh
ile us
ing th
is pr
oduc
t
Drug
Fact
s (co
ntinu
ed)
• tak
e m
ore
or fo
r a lo
nger
time
than
dire
cted
Hear
t atta
ck a
nd s
troke
war
ning
: NSA
IDs,
exce
pt a
spirin
,inc
reas
e th
e ris
k of h
eart
atta
ck, h
eart
failu
re, a
nd st
roke
.The
seca
n be
fata
l.The
risk
is h
igher
if yo
u us
e m
ore
than
dire
cted
orfo
r lon
ger t
han
direc
ted.
Do n
ot u
se• if
you
have
ever
had
anall
ergic
reac
tion
toan
yoth
erpa
inre
lieve
r/fev
er re
duce
r• r
ight b
efor
e or
afte
r hea
rt su
rger
yAs
k a
doct
or b
efor
e us
e if
• the
stom
ach
bleed
ing w
arnin
g ap
plies
to yo
u• y
ou h
ave
a his
tory
of s
tom
ach
prob
lems,
such
as h
eartb
urn
• you
hav
e hig
h blo
od p
ress
ure,
hea
rt dis
ease
, live
r cirr
hosis
,kid
ney d
iseas
e, a
sthm
a, o
r had
a st
roke
• you
are
takin
g a
diure
tic• y
ou h
ave
prob
lems o
r ser
ious s
ide e
ffects
from
takin
g pa
inre
lieve
rs o
r fev
er re
duce
rsAs
k a
doct
or o
r pha
rmac
ist b
efor
e us
e if
you
are
• und
er a
doc
tor's
care
for a
ny se
rious
cond
ition
• tak
ing a
spirin
for h
eart
attac
k or s
troke
, bec
ause
nap
roxe
n m
ayde
crea
se th
is be
nefit
of a
spirin
• tak
ing a
ny o
ther
dru
gW
hen
usin
g th
is p
rodu
ct• t
ake
with
food
or m
ilk if
stom
ach
upse
t occ
urs
Stop
use
and
ask
a d
octo
r if
• you
exp
erien
ce a
ny o
f the
follo
wing
sign
s of s
tom
ach
bleed
ing:
• fee
l faint
• v
omit b
lood
• hav
e blo
ody o
r blac
k sto
ols• h
ave
stom
ach
pain
that
doe
s not
get
bet
ter
• you
hav
e sy
mpt
oms o
f hea
rt pr
oblem
s or s
troke
:• c
hest
pain
•
tro
uble
brea
thing
• wea
knes
s in
one
part
or si
de o
f bod
y• s
lurre
d sp
eech
• le
g sw
elling
• p
ain g
ets w
orse
or l
asts
mor
e th
an 10
day
s• f
ever
get
s wor
se o
r las
ts m
ore
than
3 d
ays
• you
hav
e dif
ficult
y swa
llowi
ng• it
feels
like
the
pill is
stuc
k in
your
thro
at• r
edne
ss o
r swe
lling
is pr
esen
t in th
e pa
inful
area
• any
new
sym
ptom
s app
ear
Drug
Fact
s (co
ntinu
ed)
If pr
egna
nt o
r bre
ast-f
eedi
ng,a
sk a
hea
lthpr
ofes
siona
l bef
ore
use.
It is
esp
ecial
lyim
porta
nt n
ot to
use
nap
roxe
n so
dium
dur
ingth
e las
t 3 m
onth
s of p
regn
ancy
unle
ssde
finite
ly dir
ecte
d to
do
so b
y a d
octo
rbe
caus
e it m
ay ca
use
prob
lems i
n th
e un
born
child
or c
ompli
catio
ns d
uring
deli
very.
Keep
out
of r
each
of c
hild
ren.
In
case
of
over
dose
, get
med
ical h
elp o
r con
tact
aPo
ison
Cont
rol C
ente
r righ
t awa
y.
Dire
ctio
ns• d
o no
t tak
e m
ore
than
dire
cted
• the
small
est e
ffect
ive d
ose s
houl
d be
use
d
• drin
k a fu
ll glas
s of w
ater
with
eac
h do
seAd
ults a
nd
• take
1 ta
blet e
very
8 to
12ch
ildre
n 12
hour
s whil
e sy
mpt
oms l
ast
year
s and
• fo
r the
first
dose
you
may
older
take
2 ta
blets
with
in th
e
fir
st ho
ur
• d
o no
t exc
eed
2ta
blets
in
an
y 8- t
o 12
-hou
r per
iod
• d
o no
t exc
eed
3ta
blets
in
a
24-h
our p
eriod
Child
ren
unde
r • a
sk a
doc
tor
12 ye
ars
Othe
r inf
orm
atio
n• e
ach
tabl
et c
onta
ins:
sodiu
m 2
0 m
g
• sto
re a
t 20-
25°C
(68-
77°F
). Av
oid h
ighhu
midi
ty a
nd e
xces
sive
heat
abo
ve40
°C (1
04°F
).
Inac
tive
ingr
edie
nts
FD&C
blue
#2
lake,
hyp
rom
ellos
e, m
agne
sium
stea
rate
,m
icroc
rysta
lline
cellu
lose,
poly
ethy
lene
glyco
l,po
vidon
e, ta
lc, tit
anium
diox
ide
Drug
Fact
s (co
ntinu
ed)
Ques
tions
or c
omm
ents
? 1-8
00-3
95-0
689
(Mon
-Fri
9AM
– 5
PM E
ST)
®®
napro
xen s
odium
table
ts, 22
0 mg(
NSAI
D)Pa
in rel
iever/
fever
reduce
r
STR
ENG
THTO
LAST
12H
OU
RS
HEA
DACH
E PA
IN
For t
empo
rary
relie
fof
hea
dach
e pa
in
50 TAB
LETS
Drug Facts Title
Drug Facts Continued
Headings*
Subheadings
Body Text
Bullets
Leading
Hairlines
Box and Barlines†
Characters Per Inch:
>8 pt **
8 pt
8 pt-bold italic*
≥6 pt
≥6 pt
5 pt
≥0.5 pt
0.5 pt rule
>0.5 pt rule
No more than 39
8.1 pt
8 pt
8 pt
6 pt
6 pt
12 pt
0 - 0.5 pt
0.5 pt
2.5 pt
≤39
DRUG FACTS INFO (updated 5/18/18)
CATEGORY REQUIRED ACTUAL IN FILE
* Headings are to be at least 2pts larger than Body Text.** Drug Facts Title to be larger than all other type size used in DFP† FDA Recommends 2.5pt rule
* Headings are to be at least 2pts larger than Body Text.** Drug Facts Title to be larger than all other type size used in DFP† FDA Recommends 2.5pt rule
Do not use if foil seal imprinted with“Bayer HealthCare” on bottle openingis missing or broken.
STRENGTH TO LAST 12 HOURS 100 TABLETS
FDA00237-3Reference ID: 4605630
Reference ID: 4605630
Bayor HealthCare
Bayor HealthCare
Bayer HealthCare
Bayor HealthCare
Bayor HealthCare
Bayor HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer He.althCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HoalthCaro
Bayer HoalthCaro
Bayer HealthCare
Bayer HealthCare
Bayer HoalthCaro
Bayer HoalthCaro
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HoalthCaro
Bayer HoalthCaro
Bayer HoalthCaro
Bayer HealthCare
Bayer HealthCare
Bayer He.althCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Bayer HealthCare
Reference ID: 4605630
--------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically. Following this are manifestations of any and allelectronic signatures for this electronic record.--------------------------------------------------------------------------------------------/s/------------------------------------------------------------