Tabradol: Package Insert and Label Information

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

Structured Suspension Vehicle
(click image for full-size original)

Flavor Label

Structured Flavor vehicle label
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Instructions Insert


Instructions
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Instructions

Instructiond
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Instructions

Instructions
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Cyclobenzaprine drug Label

Cyclobenzaprine label
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Principal Display Panel

package label
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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

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