SYNAPRYN  - tramadol hydrochloride   
Fusion Pharmaceuticals LLC

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SYNAPRYN

Principal Display Panel

Do not use if safety seal is broken

NDC 43093-100-01

Rx only

FusePaq™  Compounding Kit for Oral Suspension

SYNAPRYN™

(tramadol hydrochloride 10 mg/mL, in oral suspension with glucosamine - compounding kit)

When compounded according to directions, this kit makes 500 mL of an oral suspension containing 10 mg/mL tramadol hydrochloride with glucosamine


Contents:

For Prescription Compounding Only

U.S. Patents Pending

Synapryn Carton
Tramadol Label
Suspension Label
Flavor Label

Instructions Insert

NDC 43093-100-01

Rx only

FusePaq™

SYNAPRYN™

(tramadol hydrochloride 10 mg/mL, in oral suspension with glucosamine - 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 500 mL of an oral suspension containing 10mg/mL tramadol hydrochloride with glucosamine.


Contents:

Instructions for the Pharmacist

1    Remove and Inspect the Contents of the Kit

Ensure that the safety seals are present and intact on the tramadol 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 tramadol hydrochloride bottle.

3    Transfer Tramadol Hydrochloride to the Flavor Bottle

Flip the tip up on the suspension bottle cap. Squeeze a small amount of liquid suspension (approximately 10 mL) into the tramadol hydrochloride bottle. Cap the tramadol hydrochloride bottle and shake well several times. Empty the contents into the flavor bottle. Repeat this step 3 times. Visually ensure that all of the tramadol hydrochloride has been transferred to the flavor bottle. 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 tramadol 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


CS16-A1 rev 4


Insert Page 1

Insert Page 2


SYNAPRYN 
tramadol hydrochloride   kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 43093-100
Packaging
# NDC Package Description Multilevel Packaging
1 43093-100-01 1 KIT In 1 KIT None
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, GLASS   5 g
Part 2 1 BOTTLE, PLASTIC   250 mL
Part 3 1 BOTTLE, PLASTIC   250 mL
Part 1 of 3
TRAMADOL HYDROCHLORIDE 
tramadol hydrochloride   powder, for suspension
Product Information
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tramadol Hydrochloride (Tramadol) Tramadol Hydrochloride 5 g  in 5 g
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 5 g In 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
bulk ingredient 09/14/2009

Part 2 of 3
STRUCTURED SUSPENSION VEHICLE 
suspension   liquid
Product Information
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
No Active Ingredients Found
Inactive Ingredients
Ingredient Name Strength
Water  
Glycerin  
Sorbitol  
Glucosamine Sulfate  
Saccharin Sodium  
Citric Acid  
Potassium Sorbate  
Sodium Benzoate  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 250 mL In 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 09/14/2009

Part 3 of 3
STRUCTURED FLAVORING VEHICLE 
flavor   liquid
Product Information
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
No Active Ingredients Found
Inactive Ingredients
Ingredient Name Strength
Water  
Glycerin  
Cherry  
Xanthan Gum  
Citric Acid  
Sodium Citrate  
Potassium Sorbate  
Sodium Benzoate  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 250 mL In 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 09/14/2009


Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 09/14/2009

Labeler - Fusion Pharmaceuticals LLC (021420944)
Establishment
Name Address ID/FEI Operations
Fusion Pharmaceuticals LLC 021420944 repack
Revised: 09/2009 Fusion Pharmaceuticals LLC