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 L.N.K. International, Inc., Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (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 bowl habits that lasts over 2 weeks

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowl 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 of age: take 1 capsule daily
• children under 2 years of age: ask a doctor

Other information

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

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal display panel

Quality 
+ Plus

NDC: 50844-655-56

*Compare to active ingredient in
Dulcolax® Stool Softener 

STOOL SOFTENER 

Docusate Sodium 100 mg
STOOL SOFTENER LAXATIVE

Comfortable, Stimulant-Free
Constipation Relief

25 Liquid Gels

ACTUAL SIZE

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

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

50844    ORG011565556

Product of China
Packaged and Quality Assured in the USA

Distributed by:
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA

Quality Plus 44-655

INGREDIENTS AND APPEARANCE

STOOL SOFTENER 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50844-655
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	ORANGE	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: 50844-655-56	1 in 1 CARTON	03/01/2015
1		25 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	03/01/2015

Labeler - L.N.K. International, Inc. (038154464)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd		421293287	API MANUFACTURE(50844-655)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(50844-655)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(50844-655)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(50844-655)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(50844-655)