STOOL SOFTENER GENTLE RELIEF- docusate sodium capsule

Stool Softener by

Drug Labeling and Warnings

Stool Softener by is a Otc medication manufactured, distributed, or labeled by EQUATE (Walmart Stores, Inc.), P and L Development of New York Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

• temporary relief of occasional constipation
• this product generally produces a bowel movement within 12 to 72 hours.

Warnings - Do not use

• if abdominal pain, nausea or vomiting are present

Ask a doctor before use if

• you notice a sudden change in bowel habits that persists over a period of 2 weeks
• you are presently taking mineral oil

Stop use and ask a doctor if

• rectal bleeding or failure to have a bowel movement occur after use which may indicate 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 6 mg
• store at controlled room temperature 15o - 30o C (59o- 86o F)

Inactive Ingredients

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special.

Questions or Comments ?

Call toll free: 1-888-287-1915

Principal Display Panel

Compare to Dulcolax® Stool Softener*

Gentle Relief

stool softener

Docusate sodium 100 mg

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by: Wal-mart stores, Inc., Bentonville, AR 72716

©Wal-mart stores, Inc.

*This product is not manufactured or distributed by Boehringer Ingelheim Consumer Healthcare owner of the registered trademark of Dulcolax®

Product Label

Docusate Sodium 100 mg

INGREDIENTS AND APPEARANCE

STOOL SOFTENER  GENTLE RELIEF
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-005
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	P51
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-005-25	1 in 1 BOX
1		25 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	03/31/2011

Labeler - EQUATE (Walmart Stores, Inc.) (051957769)

Registrant - P and L Development of New York Corporation (800014821)