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Name:Tabradol
Manufacturer:Fusion Pharmaceuticals Llc
Category:Prescription Marketed Drugs


TABRADOL

TABRADOL  - cyclobenzaprine hydrochloride   
Fusion 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

Principal Display Panel

Do not use if safety seal is broken

NDC 43093-101-01

Rx only

FusePaq™  Compounding Kit for Oral Suspension

TABRADOL™

(cyclobenzaprine hydrochloride 1 mg/mL, in oral suspension with MSM - compounding kit)

When compounded according to directions, this kit makes 250 mL of an oral suspension containing 1 mg/mL cyclobenzaprine hydrochloride with MSM.


Contents:

  • 0.25 g cyclobenzaprine hydrochloride, USP
  • 250 mL bottle containing 125 mL flavor vehicle (purified water, glycerin, cherry flavor, xanthan gum, sodium citrate, citric acid, potassium sorbate, sodium benzoate)
  • 125 mL bottle containing 125 mL suspension vehicle (purified water, methyl sulfonyl methane [MSM], glycerin, sorbitol, sodium saccharin, citric acid, potassium sorbate, sodium benzoate)
  • Bottle adaptor for oral syringe
  • Oral syringe
  • Instructions

For Prescription Compounding Only

U.S. Patents Pending

Tabradol Carton
Cyclobenzaprine Label
Suspension Label
Flavor Label

Instructions Insert

NDC 43093-101-01

Rx only

FusePaq™

TABRADOL™

(cyclobenzaprine hydrochloride 1 mg/mL, in oral suspension with MSM - compounding kit)


FusePaq™ compounding kits provide a convenient approach to rapidly compound prescription medications, as all components are pre-measured. This kit is manufactured according to US FDA current Good Manufacturing Practice (cGMP).


For Prescription Compounding Only


Description:


When compounded according to directions, this kit makes 250 mL of an oral suspension containing 1 mg/mL cyclobenzaprine hydrochloride with MSM.


Contents:

  • 0.25 g cyclobenzaprine hydrochloride, USP
  • 250 mL bottle containing 125 mL flavor vehicle (purified water, glycerin, cherry flavor, xanthan gum, sodium citrate, citric acid, potassium sorbate, sodium benzoate)
  • 125 mL bottle containing 125 mL suspension vehicle (purified water, methyl sulfonyl methane [MSM], glycerin, sorbitol, sodium saccharin, citric acid, potassium sorbate, sodium benzoate)
  • Bottle adaptor for oral syringe
  • Oral syringe
  • Instructions

Instructions for the Pharmacist

1    Remove and Inspect the Contents of the Kit

Ensure that the safety seals are present and intact on the cyclobenzaprine hydrochloride, flavor, and suspension vehicle bottles. If the seals are not intact, do not use the kit.

2    Prepare for Mixing

Wear gloves and eye protection during compounding operations. Remove the seals from the flavor and suspension bottles. Break the perforated seal and remove the cap from the cyclobenzaprine hydrochloride bottle.

3    Transfer Cyclobenzaprine Hydrochloride to the Flavor Bottle

Flip the tip up on the suspension bottle cap. Squeeze suspension into the cyclobenzaprine hydrochloride bottle until at least half full. Cap the cyclobenzaprine hydrochloride bottle and shake well several times. Ensure that the cyclobenzaprine hydrochloride powder has been completely dissolved. Empty the contents into the flavor bottle. Cap the flavor bottle and mix well. Again fill the cyclobenzaprine hydrochloride bottle with liquid suspension vehicle, then cap and shake bottle. Transfer contents to flavor bottle. Repeat the rinsing of the cyclobenzaprine hydrochloride bottle with suspension one last time. Transfer the remaining suspension vehicle into the flavor bottle.

4    Complete the Mixing Process

Press the oral syringe adaptor into the flavor bottle. Recap the flavor bottle which now contains the cyclobenzaprine hydrochloride, suspension, and flavor. Shake well by inverting repeatedly several times.

5    Re-label the Compounded Suspension

Label the compounded suspension per the pharmacy's standard practice. Remove or obscure the flavor vehicle label, since the label is no longer accurate once compounding is completed.


Store the unused kit at room temperature of 15-30C (59-86F). Once prepared, store the mixed suspension between 15-30C (59-86F). The compounded suspension is stable for at least eight weeks based upon real-time and accelerated stability studies. Each lot of suspension vehicle and flavor vehicle is tested to meet microbial limits per USP Microbial Limit Test 61. In addition, the suspension vehicle and flavor vehicle formulations have each passed the USP 51 Antimicrobial Effectiveness Test.

An oral syringe is provided in the kit and may be used to facilitate accurate delivery of the suspension.


U.S. Patents Pending


Manufactured by:
Fusion Pharmaceuticals LLC
768 Calle Plano
Camarillo, CA 93012


CS34-A1 rev 2


Insert Page 1

Insert Page 2


TABRADOL 
cyclobenzaprine hydrochloride kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43093-101
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43093-101-01 1 KIT ( KIT) in 1 KIT None
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, GLASS   .25 g
Part 2 1 BOTTLE, PLASTIC   125 mL
Part 3 1 BOTTLE, PLASTIC   125 mL
Part 1 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 .25 g  in .25 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 .25 g in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
bulk ingredient 09/17/2009

Part 2 of 3
STRUCTURED SUSPENSION VEHICLE 
suspension liquid
Product Information
Route of Administration ORAL DEA Schedule     
Inactive Ingredients
Ingredient Name Strength
Water  
Glycerin  
Sorbitol  
Saccharin Sodium  
Citric Acid  
Potassium Sorbate  
Sodium Benzoate  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
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 other 09/17/2009

Part 3 of 3
STRUCTURED FLAVORING VEHICLE 
flavor liquid
Product Information
Route of Administration ORAL DEA Schedule     
Inactive Ingredients
Ingredient Name Strength
Water  
Glycerin  
Cherry  
Xanthan Gum  
Sodium Citrate  
Citric Acid  
Potassium Sorbate  
Sodium Benzoate  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
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 other 09/17/2009


Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 09/17/2009

Labeler - Fusion Pharmaceuticals LLC (021420944)
Establishment
Name Address ID/FEI Operations
Fusion Pharmaceuticals LLC 021420944 repack

Revised: 09/2009 Fusion Pharmaceuticals LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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