Label: DOCUSATE SODIUM - SENNOSIDES 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 January 27, 2017

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

  • ACTIVE INGREDIENT

    ACTIVE iNGREDIENTS (IN EACH TABLET)

    Docusate sodium 50 mg

    Sennosides 8.6 mg

  • INACTIVE INGREDIENT

    Inactive ingredients:  carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue#2 aluminum lake, FD&C red #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 (1-800 222-1222) right away.

  • PURPOSE

    Purpose:

    Stool softener

    Stimulant laxative

  • INDICATIONS & USAGE

    Uses:  

    Relieves occasional constipation (irregularity)

    Generally produces bowel movement in 6 to 12 hours

  • WARNINGS

    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

    Directions:

    Take only my mouth, Doses may be taken as a single daily dose, prefeably in the evening, or in divided doses.

    Adults and children 12 years of age and older:  take 2-4 tablets daily

    Childreen 6 to under 12 years: take 1-2 tablets daily

    Children 2 to under 6 years: take up to 1 talet daily

    Children under 2 years: ask a doctor

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM - SENNOSIDES 
    docusate sodium - sennosides tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0229
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorpurple (BURGUNDY) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code TCL131
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0229-1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/27/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/27/2017
    Labeler - CARDINAL HEALTH (097537435)
    Registrant - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC037052099manufacture(70000-0229)