TABRADOL- cyclobenzaprine hydrochloride 
California Pharmaceuticals, LLC

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.

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Tabradol

Tabradol - Pharmacist Instructions page 2

Tabradol pharmacist instructions page 2

Tabradol - Label

Tabradol Cyclobenzaprine label

Tabradol - Inactive ingredient - flavor label

Tabradol flavor label

Tabradol - Pharmacist instructions Page 1

Tabradol - pharmacist instructions page 1

Tabradol - Principal Label

Tabradol Principal label

TABRADOL 
cyclobenzaprine hydrochloride kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70332-106
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70332-106-011 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 125 mL
Part 21 BOTTLE, GLASS 0.25 g
Part 31 BOTTLE, PLASTIC 125 mL
Part 1 of 3
STRUCTURED SUSPENSION VEHICLE 
suspension liquid
Product Information
Route of AdministrationORAL
Inactive Ingredients
Ingredient NameStrength
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 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 other01/01/2016
Part 2 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 HYDROCHLORIDE0.25 g  in 0.25 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.5 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 other01/01/2016
Part 3 of 3
STRUCTURED FLAVORING VEHICLE 
flavor liquid
Product Information
Route of AdministrationORAL
Inactive Ingredients
Ingredient NameStrength
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 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 other01/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2016
Labeler - California Pharmaceuticals, LLC (021420944)
Establishment
NameAddressID/FEIBusiness Operations
California Pharmaceuticals, LLC021420944manufacture(70332-106) , repack(70332-106)

Revised: 1/2016
Document Id: 273003a5-23aa-21e4-e054-00144ff88e88
Set id: 273003a5-23a9-21e4-e054-00144ff88e88
Version: 1
Effective Time: 20160101
 
California Pharmaceuticals, LLC