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- Suspension Label
- Flavor Label
- Instructions Insert
- Instructions
- Instructions
- Cyclobenzaprine drug Label
- Principal Display Panel
-
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)
