Label: STOOL SOFTENER DOCUSATE SODIUM- docusate sodium capsule, gelatin coated

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

Drug Label Information

Updated October 27, 2023

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  • Drug Facts

  • Active ingredient (in each softgel)

    Docusate sodium 100 mg

    Purpose

    Stool softener

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces 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 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 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.
     adults and children 12 years of age and older take 1 to 3  softgels daily
     children 2 to under 12 years of age take 1 softgel daily
     children under 2 years ask a doctor

  • Other information

    • ach softgel contains: sodium 7mg 
    • store at 15° to 30°C (59° to 86°F)
    • protect from moisture
  • Inactive ingredients

    FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special

  • Questions?

    call toll-free 1-800-935-6737

  • Package Labeling:

    Label13

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER DOCUSATE SODIUM 
    docusate sodium capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54257-902
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code SCU1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54257-902-02100 in 1 BOTTLE; Type 0: Not a Combination Product01/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00701/24/2020
    Labeler - Magno-Humphries, Inc. (063251433)
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