Fanatrex

FANATREX- gabapentin
California Pharmaceuticals, LLC

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.

Fanatrex — Pharmacist Instructions Page 1

Fanatrex — Pharmacist Instructions Page 2

Gabapentin — Label

Fanatex — Flavor Label

Fanatrex — Package Label.Principal Display

Fanatrex — Principal package label

FANATREX gabapentin kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70332-105

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70332-105-01 1 KIT in 1 KIT None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, GLASS 10.8 g Part 2 1 BOTTLE, PLASTIC 420 mL

Part 1 of 2 GABAPENTIN gabapentin powder, for suspension

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GABAPENTIN (GABAPENTIN) GABAPENTIN 10.8 g in 10.8 g

Packaging # Item Code Package Description Multilevel Packaging 1 10.5 g in 1 BOTTLE, GLASS None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2016

Part 2 of 2 ORAL SUSPENSION VEHICLE suspension liquid

Product Information Route of Administration ORAL DEA Schedule

Inactive Ingredients Ingredient Name Strength STEVIA LEAF WATER N-ACETYLGLUCOSAMINE SODIUM PHOSPHATE, DIBASIC GLYCYRRHIZIN, AMMONIATED SACCHARIN SODIUM BANANA STRAWBERRY ALTHAEA OFFICINALIS LEAF GLYCERIN ACESULFAME POTASSIUM XANTHAN GUM POTASSIUM SORBATE SODIUM BENZOATE

Packaging # Item Code Package Description Multilevel Packaging 1 420 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2016

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2016

Labeler — California Pharmaceuticals, LLC (021420944)

Establishment
Name	Address	ID/FEI	Operations
California Pharmaceuticals, LLC		021420944	manufacture (70332-105)

Revised: 01/2016 California Pharmaceuticals, LLC