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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 16, 2019

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  • ACTIVE INGREDIENTS

    active ingredients (each tablet)

    Docusate Sodium 50 mg

    Sennosides 8.6 mg

  • INACTIVE INGREDIENTS

    CARNAUBA WAX, COLLOIDAL SILICON DIOXIDE, CROSCARMELLOSE SODIUM, DIBASIC CALCIUM PHOSPHATE DIHYDRATE, FD-C RED NO. 40 ALUMINUM LAKE, HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL, SODIUM BENZOATE, STEARIC ACID, TITANIUM DIOXIDE

  • PURPOSE

    Stool Softener
    Stimulant Laxative

  • INDICATIONS AND USAGE

    RELIEVES OCCASIONAL CONSTIPATION

    GENERALLY PRODUCES BOWEL MOVEMENT IN 6-12 HOURS

  • WARNINGS

    DO NOT USE

    LAXATIVE PRODUCTS FOR LONGER THAN 1 WEEK UNLESS DIRECTED BY A DOCTOR

    IF YOU ARE PRESENTLY TAKING MINERAL OIL UNLESS DIRECTED BY A DOCTOR

  • DOSAGE AND ADMINISTRATION

    ADULTS AND CHILDREN 12 YEARS AND OVER: 2-4 TABLETS ONCE DAILY OR IN DIVIDED DOSES
    CHILDREN 6 TO UNDER 12 YEARS: 1-2 TABLETS ONCE DAILY OR IN DIVIDED DOSES
    CHILDREN 2 TO UNDER 6 YEARS; 1/2 -1 TABLET ONCE DAILY OR IN DIVIDED DOSES
    CHILDREN UNDER 2 YEARS: ASK A DOCTOR

  • 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 RIGHT AWAY

  • PRINCIPAL DISPLAY PANEL

    209R LABEL

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER AND STIMULANT LAXATIVE 
    docusate sodium and sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-209
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code TCL097
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-209-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/10/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33404/10/2019
    Labeler - TARGET CORPORATION (006961700)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC.037052099manufacture(11673-209)
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