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 Better Living Brands, LLC, 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 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 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

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

Signature ™
care
Quality Guaranteed

COMPARE TO
DulcoEase® Stool Softener
active ingredient*

NDC: 21130-655-56

Stool Softener

DOCUSATE SODIUM 100 mg
Stool Softener Laxative

Gentle
Effective
Stimulant-free
for comfortable relief

Actual Size

25 LIQUID GELS

OUR PROMISE
QUALITY & SATISFACTION
100% GUARANTEED
OR YOUR MONEY BACK.

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

DISTRIBUTED BY BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
1-888-723-3929   www.betterlivingbrandsLLC.com

*This product is not manufactured or distributed by
Boehringer Ingelheim Pharmaceuticals, Inc.,
distributors of DulcoEase® Stool Softener.
50844     REV0218A65556           Product of China
Packaged and Quality Assured in the USA

Signature Care 44-655

INGREDIENTS AND APPEARANCE

STOOL SOFTENER 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-655
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
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)

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: 21130-655-56	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 - Better Living Brands, LLC (009137209)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(21130-655)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(21130-655)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(21130-655)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(21130-655)