Label: DOCUSATE SODIUM 100MG- docusate sodium capsule

  • NDC Code(s): 45861-076-01
  • Packager: Pharmaceutica North America, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 10, 2025

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  • Active Ingredient

    Docusate sodium 100 mg

  • Purpose

    Stool softener laxative

  • 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 care professional before use.
    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.

  • KEEP OUT OF REACH OF CHILDREN

  • 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 softgels daily
     children 2 to under 12 years of age take 1 softgel daily
     children under 2 years ask a doctor

  • Other information

    • each softgel contains: sodium 7 mg
    • store at 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)

  • Inactive Ingredients

    citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink

  • Questions or comments? 1-888-788-6472

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 100MG 
    docusate sodium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45861-076
    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 RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize13mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45861-076-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00702/01/2025
    Labeler - Pharmaceutica North America, Inc. (962739699)
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