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Dicopanol

Generic Name: diphenhydramine hydrochloride
Dosage Form: kit for oral suspension

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.

Dicopanol

Principal Display Panel

Do not use if safety seal is broken

NDC 43093-104-01

Rx only

FusePaq™  Compounding Kit for Oral Suspension

Dicopanol™

(diphenhydramine hydrochloride 5 mg/mL, in oral suspension - compounding kit)


Description:
This kit contains active and inactive bulk materials to compound a diphenhydramine hydrochloride oral suspension. These instructions describe how to prepare 150 mL of a compounded oral suspension containing 5 mg/mL diphenhydramine hydrochloride. Other concentrations are possible. Exact strength of compounded suspension must be defined by the prescriber.

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Active Ingredient:

  • 0.75 g diphenhydramine hydrochloride, USP

Inactive Ingredients:

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

For Prescription Compounding Only

U.S. Patents Pending

CS68-A1 rev 0

Drug Label

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

Diphenhydramine Hydrochloride

Ethanamine, 2-(diphenylmethoxy)-N,N-dimethyl-, hydrochloride
CAS# 147-24-0

Net contents: 0.75 g
Repackaged by:
Fusion Pharmaceuticals, LLC
Camarillo, CA 93012

CS65-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, xylitol, monoammonium glycyrrhizinate, pineapple flavor, xanthan gum, stevia powder, orange flavor, citric acid, sodium citrate, melatonin, potassium sorbate, sodium benzoate

Net Contents: 150 mL (5.1 fl oz)


Manufactured for:
Fusion Pharmaceuticals, LLC
Camarillo, CA 93012

CS66-A1 rev 0

Instructions Insert

NDC 43093-104-01

Rx only

FusePaq™

Dicopanol™

(diphenhydramine hydrochloride 5 mg/mL, 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 diphenhydramine hydrochloride oral suspension. These instructions describe how to prepare 150 mL of a compounded oral suspension containing 5 mg/mL diphenhydramine hydrochloride. Other concentrations are possible. Exact strength of compounded suspension must be defined by the prescriber.


Contents:

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

Instructions for Compounding
Diphenhydramine hydrochloride, 5 mg/mL oral suspension


1    Remove and Inspect the Contents of the Kit

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


3    Transfer Diphenhydramine 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 diphenhydramine hydrochloride bottle) into the diphenhydramine hydrochloride bottle. Cap the diphenhydramine hydrochloride bottle and shake well several times to dissolve the diphenhydramine 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 diphenhydramine 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 15-30°C (59-86°F). The compounded suspension is stable for at least eight weeks, 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


CS67-A1 rev 0


Dicopanol 
diphenhydramine hydrochloride kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43093-104
Packaging
# Item Code Package Description
1 NDC:43093-104-01 1 KIT (KIT) in 1 KIT
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, GLASS 0.75 g
Part 2 1 BOTTLE, PLASTIC 150 mL
Part 1 of 2
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride powder, for suspension
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride 0.75 g  in 0.75 g
Packaging
# Item Code Package Description
1 0.75 g in 1 BOTTLE, GLASS
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     
Inactive Ingredients
Ingredient Name Strength
Water  
Glycerin  
Xylitol  
GLYCYRRHIZIN, AMMONIATED  
Pineapple  
Xanthan Gum  
Stevia Leaf  
Orange  
Citric Acid  
Sodium Citrate  
Melatonin  
Potassium Sorbate  
Sodium Benzoate  
Packaging
# Item Code Package Description
1 150 mL in 1 BOTTLE, PLASTIC
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: 02/2010
 
Fusion Pharmaceuticals LLC



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