Label: DOCUSATE SODIUM capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated July 30, 2010

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  • 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 yearsask 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

    100 mg

    Blister of 60 Capsules

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-139(NDC:0904-7889)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
    Product Characteristics
    ColorRED (Transparent red) Scoreno score
    ShapeCAPSULE (oblong softgel) Size10mm
    FlavorImprint Code P51
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67046-139-3030 in 1 BLISTER PACK
    2NDC:67046-139-6060 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/30/2010
    Labeler - Contract Pharmacy Services-PA (945429777)
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