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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)
FDA00232-4
Reference ID: 4605630
0 0 0 0 0 0 0 0
naproxen sodium tablets, 220 mg (NSAID) Pain reliever/fever reducer
LOTEXP.
STRENGTH TO LAST 12 HOURS 24 TABLETS
FDA00233-3Reference ID: 4605630
Reference ID: 4605630
000000000000
Dist. by:Bayer HealthCare LLCW
hippany, NJ 07981
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
FDA00234-3
Reference ID: 4605630
0 0 0 0 0 0 0 0 LOTEXP.
naproxen sodium tablets, 220 mg (NSAID) Pain reliever/fever reducer
STRENGTH TO LAST 12 HOURS 50 TABLETS
FDA00235-3Reference ID: 4605630
Reference ID: 4605630
00000000
0000
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
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
sm
alle
st e
ffect
ive
dose
sho
uld
beus
ed
• drin
k a fu
ll glas
s of w
ater
with
eac
h do
seAd
ults a
nd• ta
ke 1
table
t eve
ry 8
to12
child
ren
12ho
urs w
hile
sym
ptom
s las
tye
ars a
nd• fo
r the
first
dose
you
may
older
ta
ke2
table
ts wi
thin
the
first h
our
• do
not e
xcee
d 2
table
ts in
an
y 8- t
o 12
-hou
r per
iod
• do
not e
xcee
d 3
table
ts in
a
24-h
our p
eriod
Child
ren
unde
r• a
sk a
doc
tor12
year
s
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
Ques
tions
or c
omm
ents
?1-8
00-3
95-0
689
(Mon
– F
ri 9A
M –
5PM
EST
)
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
nd p
ains
due
to:
• hea
dach
e • 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
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
ase
vere
alle
rgic
reac
tion,
esp
ecial
ly in
peop
leall
ergic
to a
spirin
. Sym
ptom
s ma y
inclu
de:
• hive
s
• f
acial
swell
ing
• asth
ma
(whe
ezing
) •sh
ock
• skin
redd
ening
• r
ash
• blis
ters
If an
alle
rgic
reac
tion
occu
rs, s
top
use
and
seek
med
ical h
elp ri
ght a
way.
Stom
ach
blee
ding
war
ning
: This
prod
uct
cont
ains a
n NS
AID,
whic
h m
ay ca
use
seve
resto
mac
h ble
eding
. The
chan
ce is
high
er if
you:
• are
age
60
or o
lder
• hav
e ha
d sto
mac
h ulc
ers o
r blee
ding
prob
lems
• tak
e a
blood
thinn
ing (a
ntico
agula
nt) o
rste
roid
drug
• tak
e ot
her d
rugs
cont
aining
pre
scrip
tion
orno
npre
scrip
tion
NSAI
Ds (a
spirin
, ibup
rofe
n,na
prox
en, o
r oth
ers)
• hav
e 3
or m
ore
alcoh
olic d
rinks
eve
ry d
aywh
ile u
sing
this
prod
uct
• tak
e mor
e or fo
r a lo
nger
time t
han d
irecte
d
Drug
Fact
s (co
ntinu
ed)
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 yo
u ha
ve e
ver h
ad a
n all
ergic
reac
tion
to a
ny o
ther
pain
relie
ver/f
ever
redu
cer
• righ
t bef
ore
or a
fter h
eart
surg
ery
Ask
a do
ctor
bef
ore
use
if
• the
stom
ach
bleed
ing w
arnin
g ap
plies
to yo
u
• you
hav
e a
histo
ry o
f sto
mac
h pr
oblem
s, su
ch a
s hea
rtbur
n
• you
hav
e hig
h blo
od p
ress
ure,
hea
rt dis
ease
, live
rcir
rhos
is, ki
dney
dise
ase,
asth
ma,
or h
ad a
stro
ke
• you
are
takin
g a
diure
tic
• you
hav
e pr
oblem
s or s
eriou
s side
effe
cts fr
om 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
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
g
Whe
n us
ing
this
pro
duct
• tak
e wi
th fo
od o
r milk
if sto
mac
h up
set o
ccur
s
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:
• feel
faint
• v
omit b
lood
• hav
e blo
ody o
r blac
k sto
ols
• hav
e sto
mac
h pa
in th
at d
oes n
ot g
et b
ette
r
• you
hav
e sy
mpt
oms o
f hea
rt pr
oblem
s or s
troke
:
• che
st pa
in
• t
roub
le br
eath
ing
• wea
knes
s in
one
part
or si
de o
f bod
y
• slur
red
spee
ch
• le
g sw
elling
• pain
get
s wor
se o
r las
ts m
ore
than
10 d
ays
• fev
er g
ets w
orse
or l
asts
mor
e th
an 3
day
s
• you
hav
e dif
ficult
y swa
llowi
ng
• it fe
els lik
e th
e pil
l is st
uck i
n yo
ur th
roat
• red
ness
or s
wellin
g is
pres
ent in
the
painf
ul ar
ea
• any
new
sym
ptom
s app
ear
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
100
TAB
LETS
HEA
DACH
E PA
IN
For
tem
pora
ry re
lief
of h
eada
che
pain
®®
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
0.5 - 0.6 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
FDA00236-3
Reference ID: 4605630
HEADACHE PAIN
0 0 0 0 0 0 0 0 LOTEXP.
naproxen sodium tablets, 220 mg (NSAID)Pain reliever/fever reducer
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
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Reference ID: 4605630
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