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Tabradol

Package insert / prescribing information
Generic name: cyclobenzaprine hydrochloride
Dosage form: kit
Drug class: Skeletal muscle relaxants

Medically reviewed by Drugs.com. Last updated on Dec 22, 2022.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

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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 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)
Fusion Pharmaceuticals LLC

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