Label: DOCUSATE SODIUM - SENNOSIDES- 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

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  • ACTIVE INGREDIENT

    ACTIVE iNGREDIENTS (IN EACH TABLET)

    Docusate sodium 50 mg

    Sennosides 8.6 mg

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  • 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

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  • 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.

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  • PURPOSE

    Purpose:

    Stool softener

    Stimulant laxative

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  • INDICATIONS & USAGE

    Uses:  

    Relieves occasional constipation (irregularity)

    Generally produces bowel movement in 6 to 12 hours

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  • 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

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  • 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

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  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM - SENNOSIDES 
    docusate sodium - sennosides tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0229
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color purple (BURGUNDY) Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code TCL131
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70000-0229-1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/27/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 01/27/2017
    Labeler - CARDINAL HEALTH (097537435)
    Registrant - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    Name Address ID/FEI Business Operations
    TIME CAP LABORATORIES, INC 037052099 manufacture(70000-0229)
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