Label: STOOL SOFTENER PLUS STIMULANT LAXATIVE- docusate sodium and sennosides tablet

  • NDC Code(s): 72476-878-10
  • Packager: Care One (Retail Business Services, LLC.)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 5, 2023

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  • Active ingredients (in each tablet)

    Docusate sodium 50 mg

    Sennosides 8.6 mg

  • Purpose

    Stool softener

    Stimulant laxative

  • Uses

    • relieves ccasional constipation (irregularity)
    • generally produces bowel movement in 6 to12 hours
  • Warnings

    Do not use

    • laxative products for longer than 1 week unless told to do so by a doctor
    • if you are now 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 a period of 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.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center 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 and oldertake 2-4 tablets daily 
    children 6 to under 12 years of agetake 1-2 tablets daily 
    children 2 to under 6 years of age take up to 1 tablet daily 
    children under 2 ask a doctor 

  • Other information

    • each tablet contains: calcium 21 mg
    • each tablet contains: sodium 5 mg VERY LOW SODIUM
    • store at 25ºC (77ºF); excursions permitted between 15-30ºC(59-86ºF)
  • Inactive ingredients

    carnauba wax, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake,  hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silcon dioxide, sodium benzoate, stearic acid, titanium dioxide

  • Questions or comments?

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

  • Principal Display Panel

    *Compare to the active ingredients in Colace® 2-IN-1

    STOOL SOFTENER & STIMULANT LAXATIVE

    Docusate sodium, 50 mg

    and Sennosides, 8.6 mg

    A GENTLE, PREDICTABLE LAXATIVE

    TABLETS

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    †This product is not manufactured or distributed by Avrio Health LP., distributor of Colace® 2-IN-1.

    DISTRIBUTED BY FOODHOLD U.S.A., LLC

    LANDOVER, MD 20785 • 1-877-846-9949

  • Product Label

    Docusate Sodium 50 mg, Sennosides 8.6 mg

    CARE ONE Stool Softener and Stimulant Laxative

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER  PLUS STIMULANT LAXATIVE
    docusate sodium and sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-878
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code TCL097
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72476-878-101 in 1 BOX06/30/2020
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00706/30/2020
    Labeler - Care One (Retail Business Services, LLC.) (967989935)
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