Docusate Sodium

Dosage Form: capsule, liquid filled
Docusate Sodium 100 mg

DRUG FACTS

ACTIVE INGREDIENT (IN EACH CAPSULE)

Docusate Sodium 100 mg

PURPOSE

Stool softener

USES

• relieves occasional constipation (irregularity)
  

  generally produces a bowel movement in 12 to 72 hours

  
  

Warnings

Do not use

• if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

• stomach pain


• nausea


• vomiting


• noticed a sudden change in bowel movements that continues over a period of 2 weeks

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement after use of a laxative.
  
  These could be signs of a serious condition.


• you need to use a stool softener laxative for more than 1 week

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

• Take only by mouth. Doses may be taken as a single daily dose or in divided doses.


• 
  
  
  
  
  
  
  

  adults and children 12 years and over	take 1-3 capsules daily
  children 2 to under 12 years of age	take 1 capsules daily
  children under 2 years	ask a doctor

OTHER INFORMATION

• each capsule contains: sodium 6 mg


• store at 25°C (77°F)); excursions permitted between 15°-30°C (59°-86°F)

INACTIVE INGREDIENTS

FD&C Red No. 40, FD&C Yellow No. 6, edible ink, gelatin, glycerin, polyethylene blycol, propylene glycol, purified water and sorbitol special

QUESTIONS OR COMMENTS?

Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, U.S.A.

call toll free 734-743-6000

Repackaged by:


Contract Pharmacy Services-PA

125 Titus Ave Suite 200

Warrington, PA 18976 USA

Original--07/2010--NJW

Package Label

Blister of 60 Capsules

Docusate Sodium  Docusate Sodium  capsule, liquid filled

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 67046-139 (0904-7889) 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 No Inactive Ingredients Found

Product Characteristics Color RED (Transparent red) Score no score Shape CAPSULE (oblong softgel) Size 10mm Flavor Imprint Code P51 Contains

Packaging # NDC Package Description Multilevel Packaging 1 67046-139-30 30 CAPSULE In 1 BLISTER PACK None 2 67046-139-60 60 CAPSULE In 1 BLISTER PACK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	07/30/2010

Labeler - Contract Pharmacy Services-PA (945429777)

Revised: 07/2010Contract Pharmacy Services-PA

More Docusate Sodium resources

• Docusate Sodium Side Effects (in more detail)
• Docusate Sodium Use in Pregnancy & Breastfeeding
• Drug Images
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• Docusate Sodium Support Group
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