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 -- Instructions Page 1
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Fanatrex — Pharmacist Instructions Page 2

Fanatrex -- Instructions Pag 2
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Gabapentin — Label

Gabapentin label
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Fanatex — Flavor Label

Fanatrex -- Flavor Label
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Fanatrex — Package Label.Principal Display

Fanatrex — Principal package label

Fanatrex Principal Display label
(click image for full-size original)

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

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