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.

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Fanatrex

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

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)

Revised: 1/2016
Document Id: 28c7b43b-5ce4-60a0-e054-00144ff88e88
Set id: 2731faa1-a7a9-5c4d-e054-00144ff88e88
Version: 3
Effective Time: 20160107
 
California Pharmaceuticals, LLC