Label: 2 IN 1LAXATIVE STOOL SOFTENER AND STIULANT LAXATIVE- stool softener-stimulant laxative tablet, 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 20, 2020

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  • ACTIVE INGREDIENT

    active ingredients (each tablet)

    Docusate Sodium 50 mg

    Sennosides 8.6 mg

  • 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.

  • PURPOSE

  • PURPOSE

    Stool Softener
    Stimulant Laxative

  • INDICATIONS & USAGE

  • INDICATIONS & USAGE

    RELIEVES OCCASIONAL CONSTIPATION

    GENERALLY PRODUCES BOWEL MOVEMENT IN 6-12 HOURS

  • DOSAGE & ADMINISTRATION


    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 \
    CHILDREN 6 TO UNDER 12 YEARS: 1-2 TABLETS \DAILY \
    CHILDREN 2 TO UNDER 6 YEARS;]
    1 TABLET DAILY
    CHILDREN UNDER 2 YEARS: ASK A DOCTOR

  • 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

  • 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

    kEEP OUT OF REACH OF CHILDREN. iN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY

  • PRINCIPAL DISPLAY PANEL

    100CT

  • INGREDIENTS AND APPEARANCE
    2 IN 1LAXATIVE STOOL SOFTENER AND STIULANT LAXATIVE 
    stool softener-stimulant laxative tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-8005
    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
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code TCL097
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-8005-5100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33406/01/2020
    Labeler - RITE AID (014578892)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC.037052099manufacture(11822-8005)