Label: DOCUSATE SODIUM capsule, liquid filled

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

Drug Label Information

Updated January 9, 2025

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient (In each softgel)

    Docusate Sodium.... 100 mg

  • PURPOSE

    Purpose

    Stool softener laxative

  • INDICATIONS & USAGE

    Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 12 to 72 hours
  • WARNINGS

    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 last 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 a signs of a serious condition.
    • you need to use a stool softner 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.

  • DOSAGE & ADMINISTRATION

    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 to 3 softgels daily
    children 2 to under 12 years of age : take 1 softgel daily
    children under 2 years : ask a doctor

  • STORAGE AND HANDLING

    Other Information

    each softgel contains: sodium 5 mg
    store between 20ºC - 25ºC (68-77ºF);excursions permitted between 15-30ºC (59-86ºF)

  • INACTIVE INGREDIENT

    Gelatin, Glycerin, Sorbitol Sorbitan solution, Purified water , D&C Red #40, D&C Yellow #6, White Ink

  • QUESTIONS

    Questions or Comments ?

    Call 1-855-642-2594

  • SPL UNCLASSIFIED SECTION

    Compare to the active ingredient in Colace® Regular Strength Stool Softener†

    †This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® Regular Strength Stool Softener.

    Rev.: 03/2023

    Manufactured by:
    Apnar Pharma LLP
    East Windsor, NJ 08520

  • PRINCIPAL DISPLAY PANEL

    NDC 24689-130-01

    Docusate Sodium 100mg

    Stool Softener Laxative

    MADE IN USA

    100 Softgels

    Docusate Sodium Softgel lable-100mg

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24689-130
    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
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVAL (Oblong) Size13mm
    FlavorImprint Code AD2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24689-130-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/25/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00709/25/2023
    Labeler - APNAR PHARMA LP (079568229)
    Establishment
    NameAddressID/FEIBusiness Operations
    APNAR PHARMA LLP118530917analysis(24689-130) , manufacture(24689-130) , pack(24689-130)