STOOL SOFTENER- docusate sodium capsule, liquid filled
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

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.

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Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses

for temporary relief of occasional constipation and irregularity
this product generally produces bowel movement in 12 to 72 hours

Warnings

Ask a doctor before use if you have

stomach pain
nausea
vomiting
a sudden change in bowel habits that lasts more than 2 weeks

Ask a doctor or pharmacist before use if you are

presently taking mineral oil.

Stop use and ask a doctor if

you have rectal bleeding or no bowel movement after using 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 with a glass of water

adults and children 12 years and over	take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
children 2 to under 12 years of age	take 1 softgel daily
children under 2 years	ask a doctor

Other information

each softgel contains: sodium 7 mg
store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, medium-chain triglycerides*, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol

*may contain one or more of these ingredients

Questions or comments?

Call 1-888-309-9030

Principal Display Panel

Compare to active ingredient of Dulcolax®**

Gentle Relief

Stool Softener

Docusate Sodium 100 mg

Fast, dependable relief of occasional constipation

Softgels

**This product is not manufactured or distributed by Boehringer Ingelheim Consumer Health Care Products, Division of Boehringer Ingelheim Pharmaceuticals, Inc., and owner of the registered trademark Dulcolax®.

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 DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Product Labeling

Dollar General Stool Softener Softgels

STOOL SOFTENER
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55910-244
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	P51;S77;SCU1
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55910-244-25	1 in 1 BOX	02/28/2015	12/30/2021
1		25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	02/28/2015	12/30/2021

Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)

Revised: 12/2019

Document Id: 782a2db9-023d-448b-882f-d593b2065ccf

Set id: cba02056-acdb-45d1-8a1f-98ae0b51d2ba

Version: 4

Effective Time: 20191209

Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)