DOCUSATE SODIUM by Sam's West Inc / Aurohealth LLC / APL HEALTHCARE LIMITED DOCUSATE SODIUM capsule

DOCUSATE SODIUM by

Drug Labeling and Warnings

DOCUSATE SODIUM by is a Otc medication manufactured, distributed, or labeled by Sam's West Inc, Aurohealth LLC, APL HEALTHCARE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

(in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener

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 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 (1-800-222-1222) 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 and over: take 1-3 softgel daily
• children 2 to under 12 years of age: take 1 softgel daily
• children under 2 years: ask a doctor

Other information

• each capsule contains: sodium 5 mg Very Low Sodium
• store at 25°C (77°F); excursions permitted between 15-30ºC (59-86ºF). Keep tightly closed.

Inactive ingredients

D&C Red No.33, gelatin, glycerin, Neelicert FD&C Red No.40, Neelicert FD&C Yellow No.6, noncrystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, shellac glaze, titanium dioxide.

Questions or Comments?

Call 1-855-274-4122 (toll-free)

(Monday - Friday 8:30 AM to 5:00 PM EST)

*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.

DISTRIBUTED BY
SAM'S WEST, INC.
BENTONVILLE, AR 72716

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg (600 Capsules Container Label)

Compare to Colace®
active ingredient*

NDC: 68196-995-64

Member's Mark™

Stool
Softener

Docusate sodium 100 mg

Regular Strength

• Gentle, Dependable
• Stimulant-free

600 Softgels

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68196-995
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
GELATIN TYPE B BOVINE (160 BLOOM) (UNII: 1T8387508X)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SHELLAC (UNII: 46N107B71O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	Q04
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68196-995-64	600 in 1 BOTTLE; Type 0: Not a Combination Product	02/08/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	02/08/2018

Labeler - Sam's West Inc (051957769)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(68196-995)