GENTLE STOOL SOFTENER- docusate sodium capsule, liquid filled

Gentle Stool Softener by

Drug Labeling and Warnings

Gentle Stool Softener by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each liquid-filled capsule)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses

• relieves occasional constipation (irregularity)
  
• generally produces 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 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 (1-800-222-1222) right away.

Directions

• take with a glass of water
  
• 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 to 3 capsules daily
• children 2 to under 12 years: take 1 capsule daily
• children under 2 years: ask a doctor

Other information

• each capsule contains: sodium 6 mg
  Very Low Sodium
  
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  
• protect from excessive humidity
  
• see end flap for expiration date and lot number
  

Inactive ingredients

anhydrous citric acid, edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol

Questions or comments?

1-800-426-9391

Principal display panel

Compare to DulcoEase®
Stool Softener
active ingredient††

NDC: 0363-0655-56

Gentle & easy relief of
occasional constipation

Walgreens

Gentle Stool Softener

DOCUSATE SODIUM 100 mg /
STOOL SOFTENER LAXATIVE

25
LIQUID GELS

ACTUAL SIZE

50844 ORG021865556

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

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2018 Walgreen Co.
PRODUCT OF CHINA, PACKAGED AND
QUALITY ASSURED IN THE U.S.A.

Walgreens Pharmacist Recommended
Walgreens Pharmacist Survey

†† This product is not manufactured or
distributed by Boehringer Ingelheim
Pharmaceuticals, Inc., owner of the registered
trademark DulcoEase® Stool Softener

Walgreens 44-655

INGREDIENTS AND APPEARANCE

GENTLE STOOL SOFTENER 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0655
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
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)

Product Characteristics
Color	ORANGE (Clear)	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	655
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0655-56	1 in 1 CARTON	03/01/2015
1		25 in 1 BOTTLE, PLASTIC; 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	03/01/2015

Labeler - Walgreen Company (008965063)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd		421293287	API MANUFACTURE(0363-0655)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(0363-0655)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(0363-0655)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(0363-0655)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(0363-0655)