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Tabradol Prescribing Information

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

Medically reviewed by Drugs.com. Last updated on Mar 1, 2024.

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Tabradol Description

Structured Suspension Vehicle

Tabradol Description

Structured Flavor vehicle label

Tabradol Description


Instructions

Instructions

Instructiond

Instructions

Instructions

Tabradol Description

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)

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