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.

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TABRADOL

Suspension Label

Structured Suspension Vehicle

Flavor Label

Structured Flavor vehicle label

Instructions Insert


Instructions

Instructions

Instructiond

Instructions

Instructions

Cyclobenzaprine drug Label

Cyclobenzaprine label

Principal Display Panel

package label

TABRADOL 
cyclobenzaprine hydrochloride kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43093-101
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43093-101-011 in 1 KIT; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, GLASS 0.28 g
Part 21 BOTTLE, PLASTIC 125 mL
Part 31 BOTTLE, PLASTIC 125 mL
Part 1 of 3
CYCLOBENZAPRINE HYDROCHLORIDE 
cyclobenzaprine hydrochloride powder, for suspension
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI) CYCLOBENZAPRINE HYDROCHLORIDE0.28 g  in 0.28 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.25 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 other09/17/2009
Part 2 of 3
STRUCTURED SUSPENSION VEHICLE 
suspension liquid
Product Information
Route of AdministrationORAL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1125 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 other09/17/2009
Part 3 of 3
STRUCTURED FLAVORING VEHICLE 
flavor liquid
Product Information
Route of AdministrationORAL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CHERRY (UNII: BUC5I9595W)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1125 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 other09/17/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/17/2009
Labeler - Fusion Pharmaceuticals LLC (021420944)
Establishment
NameAddressID/FEIBusiness Operations
Fusion Pharmaceuticals LLC021420944manufacture(43093-101)

Revised: 1/2016
Document Id: 28c7b9e3-07ca-6f9b-e054-00144ff88e88
Set id: 5d19ef8b-eef3-4d52-95f5-929765ca6dc7
Version: 9
Effective Time: 20160107
 
Fusion Pharmaceuticals LLC