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 (Walmart Stores, Inc.), Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each capsule)

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 movements that lasts over 2 weeks

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement after using a laxative. These could be signs of a serious condition.
• you need to use a stool softener 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 only by mouth. Doses may be taken as a single daily dose or in divided doses.

• Adults and children 12 years of ages and over: take 1 to 3 softgels daily
• Children 2 and under 12 years of age: take 1 softgel daily
• children under 2 years of age: ask a doctor

Other information

• each softgel contains: sodium 5 mg
• VERY LOW SODIUM
• store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive ingredients

D&C Red #33, FD&C blue #1, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special, citric acid, purified water and white edible ink

Questions or comments?

Call toll free 1-888-287-1915

Principal Display Panel

Stool Softener

Docusate Sodium, 100 mg

Compare to Colacel® Stool Softener Active Ingredient*

60 Softgels

NDC  49035-115-22

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®.

Principal Display Panel

Stool Softener

Docusate Sodium, 100 mg

Compare to Colacel® Stool Softener Active Ingredient*

140 Softgels

NDC: 49035-115-34

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®.

Principal Display Panel

Stool Softener

Docusate Sodium, 100 mg

Compare to Colacel® Stool Softener Active Ingredient*

280 Softgels

NDC: 49035-115-35

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®.

INGREDIENTS AND APPEARANCE

STOOL SOFTENER 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-115
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)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
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)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color	red, white (Two-Tone)	Score	no score
Shape	CAPSULE (Oval)	Size	13mm
Flavor		Imprint Code	PC18
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-115-22	1 in 1 CARTON	02/15/2015	04/30/2020
1		60 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49035-115-35	2 in 1 PACKAGE	02/15/2015	01/31/2017
2		140 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 49035-115-34	140 in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2015	04/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	02/15/2015	04/30/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd		421293287	analysis(49035-115) , manufacture(49035-115)