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Tabradol: Package Insert / Prescribing Info

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 3, 2025.

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Tabradol Description

Structured Suspension Vehicle

Tabradol Description

Structured Flavor vehicle label

Tabradol Description


Instructions

Instructions

Instructiond

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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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