STOOL SOFTENER- docusate sodium capsule, liquid filled

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)
Available from:
Publix Supermarkets, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Stool softener laxative - relief of occasional constipation (irregularity) - generally produces bowel movement in 12 to 72 hours
Authorization status:
OTC monograph not final
Authorization number:
56062-578-10, 56062-578-60

STOOL SOFTENER- docusate sodium capsule, liquid filled

Publix Supermarkets, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpos e

Stool softener laxative

Us es

relief of occasional constipation (irregularity)

generally produces bowel movement in 12 to 72 hours

Warnings

Do not use

if you are presently taking a mineral oil, unless told to do so by a doctor.

Ask a doctor before use if you have

stomach pain

nausea

vomiting

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.

adults and children 12 years and

over

take 1-3 softgels daily

children 2 to under 12 years of

take 1 softgel daily

children under 2 years

ask a doctor

Other information

each softgel contains: sodium 6 mg

store at 77ºF (25ºC); excursions permitted between 59-86ºF(15-30ºC)

Inactive ingredients

D&C red #33*, edible ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6, gelatin, glycerin,

polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide

*contains one or more of these ingredients

Principal Display Panel

stool softener

DOCUSATE SODIUM 100 mg

LAXATIVE

Gentle

Dependable

Stimulant-free

SOFTGELS

†Compare to the active ingredient in Colace® Regular Strength Stool Softener

†This product is not manufactured or distributed by Purdue Products LP., distributor of Colace®

Regular Stool Softener.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN

OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,

3300PUBLIX CORPORATE PARKWAY,

LAKELAND, FL 33811

1-888-267-3037 publix.com

Product Label

PUBLIX Stool Softener

STOOL SOFTENER

docusate sodium capsule, liquid filled

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:56 0 6 2-578

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DO CUSATE SO DIUM (UNII: F0 5Q2T2JA0 ) (DOCUSATE - UNII:M7P2719 5AG)

DOCUSATE SODIUM

10 0 mg

Publix Supermarkets, Inc.

Inactive Ingredients

Ingredient Name

Stre ng th

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITAN (UNII: 6 O9 2ICV9 RU)

SO RBITO L (UNII: 50 6 T6 0 A25R)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

RED, WHITE

S core

no sco re

S hap e

OVAL

S iz e

12mm

Flavor

Imprint Code

P10 ;SCU2;D1

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:56 0 6 2-578 -

1 in 1 BOX

0 2/28 /20 19

1

6 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

2

NDC:56 0 6 2-578 -

1 in 1 BOX

0 2/28 /20 19

2

10 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part334

0 2/28 /20 19

Labeler -

Publix Supermarkets, Inc. (006922009)

Revised: 3/2019

Similar products

Search alerts related to this product

View documents history

Share this information