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Tabradol (Fusion Pharmaceuticals LLC)

Available Formats

Dosage Form Package Information Links
KIT 1 KIT in 1 KIT (43093-101-01) * .25 g in 1 BOTTLE, GLASS * 125 mL in 1 BOTTLE, PLASTIC * 125 mL in 1 BOTTLE, PLASTIC Label Information

Complete Tabradol Information

  • Suspension Label

    Structured Suspension Vehicle


  • Flavor Label

    Structured Flavor vehicle label


  • Instructions Insert


    Instructions


  • Instructions

    Instructiond


  • Instructions

    Instructions


  • Cyclobenzaprine drug Label

    Cyclobenzaprine label


  • Principal Display Panel

    package label


  • INGREDIENTS AND APPEARANCE
    TABRADOL 
    cyclobenzaprine hydrochloride kit
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43093-101
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43093-101-01 1 in 1 KIT; Type 0: Not a Combination Product
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BOTTLE, GLASS 0.28 g
    Part 2 1 BOTTLE, PLASTIC 125 mL
    Part 3 1 BOTTLE, PLASTIC 125 mL
    Part 1 of 3
    CYCLOBENZAPRINE HYDROCHLORIDE 
    cyclobenzaprine hydrochloride powder, for suspension
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI) CYCLOBENZAPRINE HYDROCHLORIDE 0.28 g  in 0.28 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.25 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 09/17/2009
    Part 2 of 3
    STRUCTURED SUSPENSION VEHICLE 
    suspension liquid
    Product Information
    Route of Administration ORAL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 09/17/2009
    Part 3 of 3
    STRUCTURED FLAVORING VEHICLE 
    flavor liquid
    Product Information
    Route of Administration ORAL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CHERRY (UNII: BUC5I9595W)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 09/17/2009
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 09/17/2009
    Labeler - Fusion Pharmaceuticals LLC (021420944)
    Establishment
    Name Address ID/FEI Business Operations
    Fusion Pharmaceuticals LLC 021420944 manufacture(43093-101)