Label: STOOL SOFTENER LAXATIVE- docusate sodium capsule, liquid filled

  • NDC Code(s): 72476-107-25
  • Packager: Care One (Retail Business Services, LLC.)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 5, 2024

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  • Active ingredient (in each softgel)

    Docusate Sodium USP, 100 mg

  • Purpose

    Stool softener laxative

  • Uses

    • for relief of occasional constipation and irregularity
    • this product 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

    • 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 using a laxative. These could be a sign 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 (1-800-2222-1222) right away.

  • Directions

    • take with a glass of water
    adults and children 12 years and overtake 1-3 softgels daily. This dose may be taken as a single daily dose or in divided doses
    children 2 to under 12 years of agetake 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?

     Call  1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to the active ingredient in Dulcolax® Stool Softener†

    STOOL SOFTENER LAXATIVE

    Docusate Sodium 100 mg

    FAST, DEPENDABLE RELIEF

    OF OCCASIONAL CONSTIPATION

    SOFTGELS

    †This product is not manufactured or distributed by Chattem, Inc., distributor of Dulcolax® Stool Softener.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC

    SALISBURY, NC 28147



  • Product Label

    Docusate Sodium USP, 100 mg

    CARE ONE Stool Softener Laxative

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER LAXATIVE 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-107
    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
    ShapeCAPSULESize13mm
    FlavorImprint Code PC1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72476-107-251 in 1 BOX04/30/2023
    125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00704/30/2023
    Labeler - Care One (Retail Business Services, LLC.) (967989935)
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