Label: SENNA/DOCUSATE SODIUM- docusate sodium and 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 December 26, 2018

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  • ACTIVE INGREDIENT

    Active Ingredients (in each tablet)

    Docusate Sodium 50 mg

    Sennosides 8.6 mg

  • PURPOSE

    Purpose
    Stool Softener
    Stimulant Laxative

  • INDICATIONS & USAGE

    Uses relieves occasional constipation (irregularity). This product generally produces a bowel movement in 6 to 12 hours.

  • WARNINGS

    Warnings

    Ask a doctor before use if you have

    • Stomach pain
    • Nausea
    • Vomiting
    • A sudden change in bowel habits that lasts over a period of 2 weeks.

    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

  • Ask Doctor/Pharmacist

    Ask a doctor or pharmacist before use if you are presently taking mineral oil.

  • DOSAGE & ADMINISTRATION

    Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided dose.

    Age

    Dosage

    Adults and children

    12 years of age and older

    Take 2-4 tablets daily

    Children 6 to under 12 years

    Take 1-2 tablets daily

    Children 2 to 6 years

    Take up to 1 tablet daily

    Children under 2 years

    Do not use
  • Generic Section

    Other information

    • Each tablet contains: sodium 6 mg/tablet VERY LOW SODIUM
    • Each tablet contains: calcium 20 mg/tablet.
    • Store at 20° - 25°C (68° -77°F); excursions permitted to 15°-30° (59°-86°F). [See USP Controlled Room Temperature]
  • INACTIVE INGREDIENT

    Inactive Ingredients: Carnauba Wax, Colloidal Silicon Dioxide, Croscarmellose Sodium, Dibasic Calcium Phosphate Dihydrate, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, tapioca starch*, tartaric acie*, and titanium dioxide. *may contain these ingredients.

  • 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.

  • Questions

    Questions? To Report Serious Adverse Effects Call: (800)616-2471

    Distributed By:

    Major® Pharmaceuticals

    17177 N Laurel Park Dr., Suite 233

    Livonia, MI 48152 USA

    LHC51790417

  • PRINCIPAL DISPLAY PANEL

    pdp

  • INGREDIENTS AND APPEARANCE
    SENNA/DOCUSATE SODIUM 
    docusate sodium and sennosides tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45865-913(NDC:0904-5643)
    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)  
    HYPROMELLOSE, UNSPECIFIED (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:45865-913-3030 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/01/2010
    Labeler - medsource pharmaceuticals (833685915)
    Establishment
    NameAddressID/FEIBusiness Operations
    medsource pharmaceuticals833685915repack(45865-913)
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