Tabradol

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.

Tabradol — Pharmacist Instructions page 2

Tabradol pharmacist instructions page 2
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Tabradol — Label

Tabradol Cyclobenzaprine label
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Tabradol — Inactive ingredient — flavor label

Tabradol flavor label
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Tabradol — Pharmacist instructions Page 1

Tabradol -- pharmacist instructions page 1
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Tabradol — Principal Label

Tabradol Principal label
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TABRADOL
cyclobenzaprine hydrochloride kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70332-106
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70332-106-01 1 KIT in 1 KIT None
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 DEA Schedule
Inactive Ingredients
Ingredient Name Strength
SORBITOL
WATER
GLYCERIN
CITRIC ACID MONOHYDRATE
POTASSIUM SORBATE
SODIUM BENZOATE
DIMETHYL SULFONE
SACCHARIN SODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 125 mL in 1 BOTTLE, PLASTIC None
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) CYCLOBENZAPRINE HYDROCHLORIDE 0.25 g in 0.25 g
Packaging
# Item Code Package Description Multilevel Packaging
1 0.5 g in 1 BOTTLE, GLASS None
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 DEA Schedule
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
CHERRY
CITRIC ACID MONOHYDRATE
SODIUM CITRATE
SODIUM BENZOATE
WATER
POTASSIUM SORBATE
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 125 mL in 1 BOTTLE, PLASTIC None
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 Operations
California Pharmaceuticals, LLC 021420944 manufacture (70332-106), repack (70332-106)

Revised: 01/2016 California Pharmaceuticals, LLC

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