Label: SENNA 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 September 25, 2017

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  • ACTIVE INGREDIENT

  • INACTIVE INGREDIENT

  • DOSAGE & ADMINISTRATION

  • INDICATIONS & USAGE

  • WARNINGS

  • PURPOSE

  • KEEP OUT OF REACH OF CHILDREN

  • PRINCIPAL DISPLAY PANEL

    LABEL

  • INGREDIENTS AND APPEARANCE
    SENNA 
    senna tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-677(NDC:0904-6434)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code TCL080
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67046-677-077 in 1 BLISTER PACK; Type 0: Not a Combination Product09/25/2017
    2NDC:67046-677-6260 in 1 BLISTER PACK; Type 0: Not a Combination Product09/25/2017
    3NDC:67046-677-1414 in 1 BLISTER PACK; Type 0: Not a Combination Product09/25/2017
    4NDC:67046-677-1515 in 1 BLISTER PACK; Type 0: Not a Combination Product09/25/2017
    5NDC:67046-677-6060 in 1 BLISTER PACK; Type 0: Not a Combination Product09/25/2017
    6NDC:67046-677-2020 in 1 BLISTER PACK; Type 0: Not a Combination Product09/25/2017
    7NDC:67046-677-2121 in 1 BLISTER PACK; Type 0: Not a Combination Product09/25/2017
    8NDC:67046-677-3030 in 1 BLISTER PACK; Type 0: Not a Combination Product09/25/2017
    9NDC:67046-677-2828 in 1 BLISTER PACK; Type 0: Not a Combination Product09/25/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/25/2017
    Labeler - Contract Pharmacy Services-PA (945429777)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coupler Enterprises Inc.945429777relabel(67046-677)