Label: TABRADOL- cyclobenzaprine hydrochloride kit
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Contains inactivated NDC Code(s)
NDC Code(s): 43093-101-01 - Packager: Fusion Pharmaceuticals LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated January 7, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Suspension Label
- Flavor Label
- Instructions Insert
- Instructions
- Instructions
- Cyclobenzaprine drug Label
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
TABRADOL
cyclobenzaprine hydrochloride kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43093-101 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43093-101-01 1 in 1 KIT; Type 0: Not a Combination Product 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 suspensionProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI) CYCLOBENZAPRINE HYDROCHLORIDE 0.28 g in 0.28 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 0.25 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 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 liquidProduct Information Route of Administration ORAL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 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 liquidProduct Information Route of Administration ORAL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 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 Business Operations Fusion Pharmaceuticals LLC 021420944 manufacture(43093-101)
