Label: FANATREX- gabapentin kit

  • Category: HUMAN PRESCRIPTION DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 7, 2016

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Fanatrex - Pharmacist Instructions Page 1

    Fanatrex - Instructions Page 1

  • Fanatrex - Pharmacist Instructions Page 2

    Fanatrex - Instructions Pag 2

  • Gabapentin - Label

    Gabapentin label

  • Fanatex - Flavor Label

    Fanatrex - Flavor Label

  • Fanatrex - Package Label.Principal Display

  • Fanatrex - Principal package label

    Fanatrex Principal Display label

  • INGREDIENTS AND APPEARANCE
    FANATREX 
    gabapentin kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70332-105
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70332-105-011 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, GLASS 10.8 g
    Part 21 BOTTLE, PLASTIC 420 mL
    Part 1 of 2
    GABAPENTIN 
    gabapentin powder, for suspension
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN10.8 g  in 10.8 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    110.5 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2016
    Part 2 of 2
    ORAL SUSPENSION VEHICLE 
    suspension liquid
    Product Information
    Route of AdministrationORAL
    Inactive Ingredients
    Ingredient NameStrength
    STEVIA LEAF (UNII: 6TC6NN0876)  
    WATER (UNII: 059QF0KO0R)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    GLYCYRRHIZIN, AMMONIATED (UNII: 3VRD35U26C)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    BANANA (UNII: 4AJZ4765R9)  
    STRAWBERRY (UNII: 4J2TY8Y81V)  
    ALTHAEA OFFICINALIS LEAF (UNII: E2QQV92338)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2016
    Labeler - California Pharmaceuticals, LLC (021420944)
    Establishment
    NameAddressID/FEIBusiness Operations
    California Pharmaceuticals, LLC021420944manufacture(70332-105)