STOOL SOFTENER EXTRA STRENGTH- docusate sodium capsule, liquid filled

Stool Softener by

Drug Labeling and Warnings

Stool Softener by is a Otc medication manufactured, distributed, or labeled by EQUATE (Walmart Stores, Inc.). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Docusate Sodium 250 mg

Purpose

Stool softener laxative

Uses

• for the prevention of dry, hard stools
• for relief of occasional constipation.
• this product generally produces a bowel movement within 12 to 72 hours.

Warnings - Do not use

if you are taking mineral oil, unless directed 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 breastfeeding

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

• adults and children over 12 years of age and over: take 1 softgel daily or as directed by a doctor
  
• children under 12 years of age: ask a doctor

Other information

• each softgel contains: sodium 15 mg
• store at controlled room temperature 20o - 25o C (68o- 77o F); excursions permitted between 15o- 30oC (59o- 86o F)

Inactive Ingredients

edible white ink, FD&C Red No# 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified wter, sorbitol special.

Questions or comments?

Call 1-888-287-1915

Principal Display Panel

Extra Strength

Stool Softener

Docusate Sodium 250 mg

• Relieves constipation
• Gentle and effective
• Stimulant free for comforable relief

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

Satisfaction guaranteed- For questions or comments please call 1-888-287-1915

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

* This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Colace®

Product Label

 

Docusate sodium 250 mg softgels

INGREDIENTS AND APPEARANCE

STOOL SOFTENER  EXTRA STRENGTH
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-150
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	250 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	CAPSULE	Size	20mm
Flavor		Imprint Code	P20
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-150-14	140 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	02/24/2014

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