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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 13, 2024

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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
    • store at 20°- 25°C (68°- 77°F); excursions permitted between 15°-30°C (59°-86°F)
  • INACTIVE INGREDIENTS

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

  • QUESTIONS?

    call 1-800-630-8895

  • PRINCIPAL DISPLAY PANEL

    01b lbl-PDP_Docusate Sodium_250mg_100

    01b lbl-DF_Docusate Sodium_250mg_100

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM, EXTRA STRENGTH   250 MG
    docusate sodium capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80513-100
    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
    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
    ShapeOVALSize12mm
    FlavorImprint Code SCU1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80513-100-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00709/15/2022
    Labeler - Advanced Rx LLC (042795108)
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