Docusate Sodium by McKesson Corporation / Contract Packaging Resources Inc. Drug Facts

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by McKesson Corporation, Contract Packaging Resources Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOCUSATE SODIUM- docusate sodium capsule, liquid filled 
McKesson Corporation

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Drug Facts

Active ingredient (in each capsule)

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 ifyou 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

• Adults and children over 12 years of age:take 1-2 capsules, preferably at bedtime
• Children 6-12 years of age:take 1 capsule at bedtime

Other information

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

Inactive ingredients

FD&C red #40, gelatin, glycerin, polyethylene glycol, propyleneglycol and sorbitol special. May also contain: D&C yellow #10, FC&C yellow #6 and purified water.

HOW SUPPLIED

Product: 63739-478

Docusate Sodium

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63739-478(NDC: 61301-8001)
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
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
WATER (UNII: 059QF0KO0R)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
FD&C RED NO. 40 (UNII: WZB9127XOA)

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: 63739-478-01	25 in 1 BOX, UNIT-DOSE	11/09/2010	02/28/2016
1		30 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 63739-478-10	10 in 1 BOX, UNIT-DOSE	11/09/2010	02/28/2016
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 63739-478-48	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/19/2017	09/21/2017
4	NDC: 63739-478-40	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/19/2017	09/21/2017
5	NDC: 63739-478-02	30 in 1 BOX, UNIT-DOSE	07/01/2021	12/24/2025
5		10 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
OTC Monograph Drug	505G(a)(3)	11/09/2010	12/24/2025

Labeler - McKesson Corporation (140529962)

Registrant - McKesson Corporation dba SKY Packaging (140529962)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Packaging Resources Inc.		960203917	repack(63739-478)

Revised: 4/2025

Document Id: 3363ba44-965f-4e58-e063-6394a90a034e

34390-5

Set id: 48555cc1-a711-411f-a384-550116da1d3c

Version: 12

Effective Time: 20250422