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Docusate Sodium

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: McKesson Corporation
NDC Code: 63739-478

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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.

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DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63739-478(NDC:61301-8001)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
GELATIN, UNSPECIFIED 
GLYCERIN 
POLYETHYLENE GLYCOL, UNSPECIFIED 
PROPYLENE GLYCOL 
SORBITOL 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
WATER 
Product Characteristics
ColorRED (Reddish) Scoreno score
ShapeOVALSize12mm
FlavorImprint CodeSCU1
Contains    
Packaging
#Item CodePackage Description
1NDC:63739-478-0125 BLISTER PACK in 1 BOX, UNIT-DOSE
130 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2NDC:63739-478-1010 BLISTER PACK in 1 BOX, UNIT-DOSE
210 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
3NDC:63739-478-40100 CAPSULE, LIQUID FILLED in 1 BOTTLE
4NDC:63739-478-481000 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other11/09/2010
Labeler - McKesson Corporation (140529962)
Establishment
NameAddressID/FEIOperations
McKesson Corporation140529962REPACK(63739-478)

Revised: 04/2014
 
McKesson Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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