ingredient in colace ® stool softener - the harvard drug

1
Docusate sodium 100 mg Stool Softener Laxative Softgels 1000 Stool Softener Gentle Dependable Stimulant-Free Re-order No. 370413 Rev. 10/17 R-58 625 R1214C NDC 0536-1062-10 Compare to the active ingredient in Colace® Regular Strength Stool Softener** Distributed by: Rugby Laboratories 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 www.rugbylaboratories.com Lot No.: Exp. Date: PLD-E1I LB005108 TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. adults and children 12 years and over children 2 to under 12 years of age children under 2 years take 1-3 softgels daily take 1 softgel daily ask a doctor Other information each softgel contains: sodium 6 mg store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F) Inactive ingredients edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol *may contain this ingredient Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST Drug Facts Active ingredient (in each softgel) Purpose Docusate sodium 100 mg..............................................................................................Stool softener laxative Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours Warnings Do not use if you are presently taking mineral oil, unless told to do so by a doctor. Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week 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 take only by mouth. Doses may be taken as a single daily dose or in divided doses. ** This product is not manufactured or distributed by Purdue Products L.P., distributor of Colace ® Regular Strength Stool Softener.

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Page 1: ingredient in Colace ® Stool Softener - The Harvard Drug

Docusate sodium 100 mgStool Softener Laxative

Softgels1000

StoolSoftenerGentleDependableStimulant-Free

Re-o

rder

No.

370

413

R

ev. 1

0/17

R-5

862

5

R121

4C

NDC 0536-1062-10

Compare to the activeingredient in Colace®

Regular StrengthStool Softener**

Dist

ribut

ed b

y:Ru

gby

Labo

rato

ries

1717

7 N

Laur

el P

ark

Driv

e, S

uite

233

Livo

nia,

MI 4

8152

ww

w.ru

gbyl

abor

ator

ies.

com

Lot N

o.:

Exp.

Dat

e:PL

D-E1

ILB

0051

08

TAMP

ER EV

IDEN

T: DO

NOT

USE

IF P

RINT

ED S

AFET

Y SE

AL U

NDER

CAP

IS B

ROKE

N OR

MIS

SING

.

adul

ts a

nd c

hild

ren

12 y

ears

and

ove

r

child

ren

2 to

und

er 1

2 ye

ars

of a

ge

child

ren

unde

r 2 y

ears

take

1-3

sof

tgel

s da

ily

take

1 s

oftg

el d

aily

ask

a do

ctor

Othe

r inf

orm

atio

n�

eac

h so

ftgel

con

tain

s: s

odiu

m 6

mg

� s

tore

at 2

5°C

(77°

F); e

xcur

sion

s pe

rmitt

ed b

etw

een

15-3

0°C

(59-

86°F

)

Inac

tive

ingr

edie

nts

edi

ble

ink,

FD&

C re

d #4

0, F

D&C

yello

w #

6, g

elat

in, g

lyce

rin, p

olye

thyl

ene

glyc

ol, p

ropy

lene

gly

col*,

pur

ified

wat

er, s

orbi

tan,

sor

bito

l*m

ay c

onta

in th

is in

gred

ient

Ques

tions

or c

omm

ents

? C

all 1

-877

-753

-393

5 M

onda

y-Fr

iday

9AM

-5PM

EST

Drug

Fac

tsAc

tive

ingr

edie

nt (i

n ea

ch s

oftg

el)

Purp

ose

Docu

sate

sod

ium

100

mg.

......

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...St

ool s

ofte

ner l

axat

ive

Uses

� re

lieve

s oc

casi

onal

con

stip

atio

n (ir

regu

larit

y)�

gen

eral

ly p

rodu

ces

bow

el m

ovem

ent i

n 12

to 7

2 ho

urs

War

ning

s Do

not

use

if y

ou a

re p

rese

ntly

taki

ng m

iner

al o

il, u

nles

s to

ld to

do

so b

y a

doct

or.

Ask

a do

ctor

bef

ore

use

if yo

u ha

ve

� s

tom

ach

pain

nau

sea

vom

iting

� n

otic

ed a

sud

den

chan

ge in

bow

el h

abits

that

last

s ov

er 2

wee

ks

Stop

use

and

ask

a d

octo

r if

� y

ou h

ave

rect

al b

leed

ing

or fa

il to

hav

e a

bow

el m

ovem

ent a

fter u

se o

f a la

xativ

e. T

hese

cou

ld b

e si

gns

of

a se

rious

con

ditio

n.�

you

nee

d to

use

a la

xativ

e fo

r mor

e th

an 1

wee

k

If pr

egna

nt o

r bre

ast-

feed

ing,

ask

a h

ealth

pro

fess

iona

l bef

ore

use.

Keep

out

of r

each

of c

hild

ren.

In c

ase

of o

verd

ose,

get

med

ical

hel

p or

con

tact

a P

oiso

n Co

ntro

l Cen

ter

right

aw

ay.

Dire

ctio

ns�

take

onl

y by

mou

th. D

oses

may

be

take

n as

a s

ingl

e da

ily d

ose

or in

div

ided

dos

es.

**Th

is p

rodu

ct is

not

man

ufac

ture

d or

dis

tribu

ted

by P

urdu

e Pr

oduc

ts L

.P.,

dist

ribut

or o

f Col

ace®

Regu

lar S

treng

th S

tool

Sof

tene

r.