TABRADOL- cyclobenzaprine hydrochloride kit

Tabradol by

Drug Labeling and Warnings

Tabradol by is a Prescription medication manufactured, distributed, or labeled by California Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Tabradol - Pharmacist Instructions page 2

Tabradol - Label

Tabradol - Inactive ingredient - flavor label

Tabradol - Pharmacist instructions Page 1

Tabradol - Principal Label

INGREDIENTS AND APPEARANCE

TABRADOL 
cyclobenzaprine hydrochloride kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70332-106

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70332-106-01	1 in 1 KIT

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	125 mL
Part 2	1 BOTTLE, GLASS	0.25 g
Part 3	1 BOTTLE, PLASTIC	125 mL

Part 1 of 3

STRUCTURED SUSPENSION VEHICLE 
suspension liquid

Product Information
Route of Administration	ORAL

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

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		01/01/2016

Part 2 of 3

CYCLOBENZAPRINE HYDROCHLORIDE 
cyclobenzaprine hydrochloride powder, for suspension

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI)	CYCLOBENZAPRINE HYDROCHLORIDE	0.25 g  in 0.25 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.5 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		01/01/2016

Part 3 of 3

STRUCTURED FLAVORING VEHICLE 
flavor liquid

Product Information
Route of Administration	ORAL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CHERRY (UNII: BUC5I9595W)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
XANTHAN GUM (UNII: TTV12P4NEE)

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		01/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2016

Labeler - California Pharmaceuticals, LLC (021420944)

Establishment
Name	Address	ID/FEI	Business Operations
California Pharmaceuticals, LLC		021420944	manufacture(70332-106) , repack(70332-106)