Label: DOCUSATE SODIUM, EXTRA STRENGTH 250 MG- docusate sodium capsule, gelatin coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 May 25, 2023

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  • ACTIVE INGREDIENT (IN EACH SOFTGEL)

    DOCUSATE SODIUM 250 MG

  • PURPOSE

    Stool softener laxative

  • 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 presently taking mineral oil, unless directed by a doctor.


    Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel habits that lasts over 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 laxative for more than 1 week

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • DIRECTIONS

    • adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
    • children under 12 years of age: ask a doctor
  • OTHER INFORMATION

    • each softgel contains: sodium 20 mg
    • Phenylketonurics: Contains phenylalanine 4 mg per softgel
    • store at 15°- 25°C (59°- 77°F)
  • INACTIVE INGREDIENTS

    FD&C red #40, FD&C yellow #6, gelatin, glycerin, ink (edible), polyethylene glycol, propylene glycol, purified water, sorbitol.

  • QUESTIONS?

    call 1-800-630-8895

  • PRINCIPAL DISPLAY PANEL

    PDP

    DF

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM, EXTRA STRENGTH  250 MG
    docusate sodium capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80513-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM250 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN TYPE B BOVINE (160 BLOOM) (UNII: 1T8387508X)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code NV12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80513-101-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/25/2023
    Labeler - Advanced Rx LLC (042795108)
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