FANATREX- gabapentin kit

Fanatrex by

Drug Labeling and Warnings

Fanatrex by is a Prescription medication manufactured, distributed, or labeled by California Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Fanatrex - Pharmacist Instructions Page 1

Fanatrex - Pharmacist Instructions Page 2

Gabapentin - Label

Fanatex - Flavor Label

Fanatrex - Package Label.Principal Display

Fanatrex - Principal package label

INGREDIENTS AND APPEARANCE

FANATREX 
gabapentin kit

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70332-105-01	1 in 1 KIT

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)	GABAPENTIN	10.8 g  in 10.8 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		10.5 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		01/01/2016

Part 2 of 2

ORAL SUSPENSION VEHICLE 
suspension liquid

Product Information
Route of Administration	ORAL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1		420 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		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	Business Operations
California Pharmaceuticals, LLC		021420944	manufacture(70332-105)