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Tabradol

Generic Name: cyclobenzaprine hydrochloride
Dosage Form: kit

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Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.

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Suspension Label

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Flavor Label

Instructions Insert


Instructions

Instructions

Cyclobenzaprine drug Label

Principal Display Panel

Tabradol 
cyclobenzaprine hydrochloride kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43093-101
Packaging
# Item Code Package Description
1 NDC:43093-101-01 1 KIT in 1 KIT
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
1 0.25 g in 1 BOTTLE, GLASS
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
1 125 mL in 1 BOTTLE, PLASTIC
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
1 125 mL in 1 BOTTLE, PLASTIC
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

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