STOOL SOFTENER- 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 (Wal-Mart Stores, Inc.), P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

• relieves occasional constipation (irregularity)
  
• generally produces a bowel movement in 12 to 72 hours

Warnings - Do not use

• if you are presently taking mineral oil, unless told to do so 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 stool softener 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 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-30ºC (59º-86ºF)

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, sorbitol special, titanium dioxide.

Questions or comments?

1-888-287-1915

Principal Display Panel

Compare to the active ingredient in Colace® *    

Stool Softener

Docusate Sodium, 100 mg

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

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

Gluten free

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

Product Labeling

Docusate sodium 100 mg capsules

INGREDIENTS AND APPEARANCE

STOOL SOFTENER 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-111
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
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)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE, RED	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	P10;51A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-111-06	1 in 1 BOX	03/01/2012	12/31/2020
1		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	03/01/2012	12/31/2020

Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)

Registrant - P & L Development, LLC (800014821)