DOCUSATE SODIUM - docusate sodium capsule, liquid filled
McKesson Packaging Services Business Unit of 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 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

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.

REPRESENTATIVE PACKAGING

Docusate Sodium 100mg Label

NDC 63739-478-01

DOCUSATE SODIUM 100 mg

STOOL SOFTENER
UD 750 Capsules (25X30)

Dist. By: McKesson Packaging Services a business unit of McKesson Corporation
7101 Weddington Rd. Concord, NC 28027

DOCUSATE SODIUM
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	63739-478
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (DOCUSATE)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL
PROPYLENE GLYCOL
SORBITOL
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
WATER

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

Packaging
#	NDC	Package Description	Multilevel Packaging
1	63739-478-01	25 BLISTER PACK In 1 BOX, UNIT-DOSE	contains a BLISTER PACK
1		30 CAPSULE In 1 BLISTER PACK	This package is contained within the BOX, UNIT-DOSE (63739-478-01)
2	63739-478-10	10 BLISTER PACK In 1 BOX, UNIT-DOSE	contains a BLISTER PACK
2		10 CAPSULE In 1 BLISTER PACK	This package is contained within the BOX, UNIT-DOSE (63739-478-10)

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

Labeler - McKesson Packaging Services Business Unit of McKesson Corporation (140529962)

Establishment
Name	Address	ID/FEI	Operations
SWISS CAPS USA, INC.		033105888	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Conctract Packaging Resources		960203917	REPACK

Establishment
Name	Address	ID/FEI	Operations
McKesson Packaging Services Business Unit of McKesson Corporation		140529962	REPACK

Revised: 10/2010McKesson Packaging Services Business Unit of McKesson Corporation