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

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.

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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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63739-478
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 
GLYCERIN 
POLYETHYLENE GLYCOL 
PROPYLENE GLYCOL 
SORBITOL 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
WATER 
Product Characteristics
ColorRED (Reddish) Scoreno score
ShapeOVALSize12mm
FlavorImprint Code SCU1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63739-478-0125 in 1 BOX, UNIT-DOSE
130 in 1 BLISTER PACK
2NDC:63739-478-1010 in 1 BOX, UNIT-DOSE
210 in 1 BLISTER PACK
3NDC:63739-478-0410 in 1 BOX
330 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other11/08/2010
Labeler - McKesson Packaging Services Business Unit of McKesson Corporation (140529962)
Establishment
NameAddressID/FEIBusiness Operations
SWISS CAPS USA, INC.033105888MANUFACTURE(63739-478)
Establishment
NameAddressID/FEIBusiness Operations
McKesson Packaging Services Business Unit of McKesson Corporation140529962REPACK(63739-478)

Revised: 11/2011
 
McKesson Packaging Services Business Unit of McKesson Corporation