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 sign of a serious condition.
you need to use a laxative for more than 1 week

If pregnant or breast-feeding,

ask a health care 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 of age 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 of age	ask a doctor

Other information

each softgel contains: sodium 7mg
store at 25ºC (77º); 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

*contains one or more of these ingredients

Questions or comments?

Call toll free 1-866-4-REXALL

Principal Display Panel

Stool Softener

Docusate Sodium, 100mg

Stimulant-free for gentle, effective relief

SOFTGELS

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

PACKAGED FOR

DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072 USA

Visit us at: Rexall.com

Product Label

Rexall Stool Softener

STOOL SOFTENER
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55910-044
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)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

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:55910-044-02	200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2015	12/30/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	06/30/2015	12/30/2021

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

Revised: 12/2019

Document Id: ef127e39-46e0-4136-81ee-544d307204ca

Set id: f7580626-b2a3-4b67-a54c-020d81823cf5

Version: 3

Effective Time: 20191209

Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)