DOCUSATE SODIUM capsule, liquid filled

DOCUSATE SODIUM by

Drug Labeling and Warnings

DOCUSATE SODIUM by is a Otc medication manufactured, distributed, or labeled by J.P. BUSINESS ENTERPRISE, MEDGEL PVT LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener

Uses

• for prevention of dry, hard stools
• for relief of occasional constipation

This product generally produces a bowel movement within 12 to 72 hours.

Warnings

Do not use

• if you are currently taking mineral oil, unless directed by a doctor
• when abdominal pain, nausea, or vomiting are present
• for longer than 1 week, unless directed by a doctor

Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if

• you have rectal bleeding
• you fail to have a bowel movement after use

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 with a glass of water

• adults and children 12 years of age and over: take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
• children 2 to under 12 years of age: take 1 softgel daily
• children under 2 years of age: consult a physician

Other information

• each softgel contains: sodium 6 mg
• store at controlled room temperature 15°-30°C (59°-86°F)
• do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

FD&C Red # 40, FD&C Yellow #6, gelatin, glycerine, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide (for printing)

Questions or comments?

Call toll free: 1-888-333-9792

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Distributed By: J.P Business Enterprise
Lake Grove, NY 11755

PRINCIPAL DISPLAY PANEL - 50 Softgel Bottle Carton

VALUMEDS

Compare to the active ingredient in
Dulcolax ® Stool Softener

STOOL SOFTENER
DOCUSATE SODIUM 100 MG

• GENTLE RELIEF
• EFFECTIVE
• STIMULANT FREE

50 SOFTGELS

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59105-007
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
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	125
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59105-007-50	1 in 1 CARTON	12/01/2014
1		50 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	12/01/2014

Labeler - J.P. BUSINESS ENTERPRISE (078775890)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PVT LTD		677385498	manufacture(59105-007)