DOCUSATE SODIUM capsule, liquid filled

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Docusate Sodium 100mg

Purpose

Stool Softener

Uses

• for the 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 have noticed 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 you are pregnant or breast-feeding, ask a health professional before use. 

This unit dose package is not child resistant and is Intended for Institutional Use Only.

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

This package is intended for institutional use only.

Consult a physician before the use of this product.

Directions

• Adults and children over 12 years of age and over: take 1-3 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 softgels daily
• Children under 2 years of age: Consult a physician

Other information

• each capsule contains: sodium 5 mg
• store at controlled room temperature 15° - 30°C (59° - 86°F)

Inactive ingredients

FD&C Red No. 40, FD&C Yellow No.6, Gelatin, Bovine Bone, Glycerol Palm Free, Polyethylene Glycol 400 NF, Purified Water, Sorbitol Special 76%.

SKY

Mfg. By:

Aenova Holding GmbH

14193 SW 119th Ave.,

Miami, FL 33186-6013

Distributed by

McKesson Packaging Services

a business unit of McKesson Corporation

7101 Weddington Road

Concord, NC 28027

Validated with McKesson's PROmanager-Rx Automated storage & dispensing system for Package-Ready Oral solids

www.PROmanager-Rx.com

Distributed by

Cardinal Health

Dublin, OH 43017

L44377781018

Principal Display Panel - Bag

Docusate Sodium 100 MG Softgels

10 Softgels

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55154-1485(NDC: 63739-478)
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)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	RED (Reddish)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	SCU1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55154-1485-0	10 in 1 BAG	11/08/2010
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		11/08/2010

Labeler - Cardinal Health (603638201)