Docusate Sodium

Pronunciation

Dosage Form: capsule, liquid filled

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Docusate Sodium 100 mg

DRUG FACTS

ACTIVE INGREDIENT (IN EACH CAPSULE)

Docusate Sodium 100 mg

Slideshow: OTC Medication Use In Pregnancy: Wise or Worrisome?

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 Item Code (Source) NDC:67046-139(NDC: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
Product Characteristics
Color RED (Transparent red) Score no score
Shape CAPSULE (oblong softgel) Size 10mm
Flavor Imprint Code P51
Contains         
Packaging
# Item Code Package Description
1 NDC:67046-139-30 30 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BLISTER PACK
2 NDC:67046-139-60 60 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BLISTER PACK
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: 07/2010
 
Contract Pharmacy Services-PA



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