Tabradol

TABRADOL- cyclobenzaprine hydrochloride
Fusion 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.

Suspension Label

Flavor Label

Instructions Insert

Instructions

Instructions

Cyclobenzaprine drug Label

Principal Display Panel

TABRADOL cyclobenzaprine hydrochloride kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43093-101

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43093-101-01 1 KIT in 1 KIT None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, GLASS 0.28 g Part 2 1 BOTTLE, PLASTIC 125 mL Part 3 1 BOTTLE, PLASTIC 125 mL

Part 1 of 3 CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride powder, for suspension

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) CYCLOBENZAPRINE HYDROCHLORIDE 0.28 g in 0.28 g

Packaging # Item Code Package Description Multilevel Packaging 1 0.25 g in 1 BOTTLE, GLASS None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/17/2009

Part 2 of 3 STRUCTURED SUSPENSION VEHICLE suspension liquid

Product Information Route of Administration ORAL DEA Schedule

Inactive Ingredients Ingredient Name Strength WATER GLYCERIN SORBITOL SACCHARIN SODIUM POTASSIUM SORBATE SODIUM BENZOATE DIMETHYL SULFONE CITRIC ACID MONOHYDRATE

Packaging # Item Code Package Description Multilevel Packaging 1 125 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/17/2009

Part 3 of 3 STRUCTURED FLAVORING VEHICLE flavor liquid

Product Information Route of Administration ORAL DEA Schedule

Inactive Ingredients Ingredient Name Strength WATER GLYCERIN CHERRY XANTHAN GUM SODIUM CITRATE POTASSIUM SORBATE SODIUM BENZOATE CITRIC ACID MONOHYDRATE

Packaging # Item Code Package Description Multilevel Packaging 1 125 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/17/2009

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/17/2009

Labeler — Fusion Pharmaceuticals LLC (021420944)

Establishment
Name	Address	ID/FEI	Operations
Fusion Pharmaceuticals LLC		021420944	manufacture (43093-101)

Revised: 01/2016 Fusion Pharmaceuticals LLC