DEPRIZINE  - ranitidine hydrochloride   
Fusion Pharmaceuticals LLC

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DEPRIZINE

Principal Display Panel

Do not use if safety seal is broken

NDC 43093-102-01

Rx only

FusePaq™  Compounding Kit for Oral Suspension

DEPRIZINE™

(ranitidine hydrochloride 16.8 mg/mL [15 mg/mL ranitidine], in oral suspension - compounding kit)

Description:
This kit contains active and inactive bulk materials to compound a ranitidine hydrochloride oral suspension. The instructions describe how to prepare 250 mL of a compounded oral suspension containing 16.8 mg/mL ranitidine hydrochloride (15 mg/mL as ranitidine). Other concentrations are possible. Exact strength of compounded suspension must be defined by the prescriber.

Active Ingredient:

• 4.2 g ranitidine hydrochloride, USP

Inactive Ingredients:

• 250 mL oral suspension vehicle (water, glycerin, L-glutamine, xylitol, monoammonium glycyrrhizinate, pineapple flavor, xanthan gum, stevia powder, orange flavor, sodium citrate, citric acid, potassium sorbate, sodium benzoate)
• Press-in bottle adaptor for oral dispenser
• Oral dispenser
• Instructions
  

For Prescription Compounding Only

U.S. Patents Pending

CS38-A1 rev 1

Drug Label

Do not use if safety seal is broken
For Prescription Compounding Only

Ranitidine Hydrochloride

1,1-Ethenediamine, N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]-methyl]thio]ethyl]-N'-methyl-2-nitro-, monohydrochloride
CAS# 66357-59-3

Net contents: 4.2 g
Repackaged by:
Fusion Pharmaceuticals, LLC
Camarillo, CA 93012

CS35-A1 rev 0

Suspension Label

Do not use if safety seal is broken
For Prescription Compounding Only

Oral Suspension Vehicle
Sugar, dye, and paraben free

Ingredients: water, glycerin, L-glutamine, xylitol, monoammonium glycyrrhizinate, pineapple flavor, xanthan gum, stevia powder, orange flavor, citric acid, sodium citrate, potassium sorbate, sodium benzoate

Net Contents: 250 mL (8.4 fl oz)

Manufactured for:
Fusion Pharmaceuticals LLC
Camarillo, CA 93012

CS36-A1 rev 0

Instructions Insert

NDC 43093-102-01

Rx only

FusePaq™

DEPRIZINE™

(ranitidine hydrochloride 16.8 mg/mL [15 mg/mL ranitidine], in oral suspension - 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:

This kit contains active and inactive bulk materials to compound a ranitidine hydrochloride oral suspension. These instructions describe how to prepare 250 mL of a compounded oral suspension containing 16.8 mg/mL ranitidine hydrochloride (15 mg/mL as ranitidine). Other concentrations are possible. Exact strength of compounded suspension must be defined by the prescriber.

Contents:

• 4.2 g ranitidine hydrochloride, USP
• 250 mL oral suspension vehicle (water, glycerin, L-glutamine, xylitol, monoammonium glycyrrhizinate, pineapple flavor, xanthan gum, stevia powder, orange flavor, citric acid, sodium citrate, potassium sorbate, sodium benzoate)
• Press-in bottle adaptor for oral dispenser
• Oral dispenser
• Instructions

Instructions for Compounding
Ranitidine hydrochloride, 16.8 mg/mL (15 mg/mL as ranitidine) oral suspension

1    Remove and Inspect the Contents of the Kit

Ensure that the safety seals are present and intact on the ranitidine hydrochloride and oral 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 seal from the oral suspension bottle. Break the perforated seal and remove the cap from the ranitidine hydrochloride bottle.

3    Transfer Ranitidine Hydrochloride to the Suspension Bottle

Uncap the suspension bottle. Pour a small amount of suspension liquid (approximately one-third to one-half the volume of the ranitidine hydrochloride bottle) into the ranitidine hydrochloride bottle. Cap the ranitidine hydrochloride bottle and shake well several times to dissolve the ranitidine hydrochloride powder. Empty the contents into the suspension bottle. Cap and mix the suspension bottle. Repeat this step 3 times. Visually ensure that all of the ranitidine hydrochloride has been dissolved and transferred to the suspension bottle.

4    Complete the Mixing Process

Insert the press-in bottle adaptor into the suspension bottle. Recap the suspension bottle. Mix 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 oral suspension vehicle label, since the label is no longer accurate once compounding is completed.

Store the unused kit at room temperature of 15-30°C (59-86°F). Once prepared, store the mixed suspension between 2-8°C (36-46°F) . The compounded suspension is stable for at least eight weeks when stored under refrigeration, based upon real-time and accelerated stability studies.

Each lot of suspension vehicle is tested to meet microbial limits per USP Microbial Limit Test <61>. In addition, the suspension vehicle formulation has passed the USP <51> Antimicrobial Effectiveness Test.

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

U.S. Patents Pending

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

CS43-A1 rev 1

DEPRIZINE  ranitidine hydrochloride   kit

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 43093-102

Packaging # NDC Package Description Multilevel Packaging 1 43093-102-01 1 KIT In 1 KIT None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, GLASS   4.2 g Part 2 1 BOTTLE, PLASTIC   250 mL

Part 1 of 2 RANITIDINE HYDROCHLORIDE  ranitidine hydrochloride   powder, for suspension

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ranitidine Hydrochloride (Ranitidine) Ranitidine Hydrochloride 4.2 g  in 4.2 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 4.2 g In 1 BOTTLE, GLASS None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/08/2010

Part 2 of 2 ORAL 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   Glutamine   Xylitol   GLYCYRRHIZIN, AMMONIATED   Pineapple   Xanthan Gum   Stevia Leaf   Orange   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 drug other 02/08/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/08/2010

Labeler - Fusion Pharmaceuticals LLC (021420944)

Establishment
Name	Address	ID/FEI	Operations
Fusion Pharmaceuticals LLC		021420944	manufacture

Revised: 02/2010Fusion Pharmaceuticals LLC