STOOL SOFTENER- docusate sodium capsule, liquid filled
EQUATE (Walmart Stores, Inc.)

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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Stool Softener

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®.

Stool Softener - 60 Softgels

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®.

Stool Softener - 140 Softgels

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®.

Stool Softener - 280 Softgels

STOOL SOFTENER
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-115
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)
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	02/15/2015	04/30/2020

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

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

Revised: 12/2017

Document Id: 6013756e-6b7d-e5a7-e053-2a91aa0abcbe

Set id: a774c6c7-f3c6-4919-be3e-27a60a6ea1d2

Version: 3

Effective Time: 20171211

EQUATE (Walmart Stores, Inc.)