Label: SENNOSIDES AND DOCUSATE SODIUM tablet, film coated

  • 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 August 13, 2012

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

  • ACTIVE INGREDIENT

    active ingredients (each tablet)

    Docusate Sodium 50 mg

    Sennosides 8.6 mg

  • PURPOSE


    Stool Softener
    Stimulant Laxative
  • INDICATIONS & 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 & 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
  • INACTIVE INGREDIENT

    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.

  • 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

    209RLABELEnter section text here

  • INGREDIENTS AND APPEARANCE
    SENNOSIDES AND DOCUSATE SODIUM  
    sennosides and docusate sodium tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-097
    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)  
    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 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:49483-097-01100 in 1 BOTTLE, PLASTIC
    2NDC:49483-097-00100000 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/01/2010
    Labeler - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC037052099manufacture(49483-097)