Dicopanol

diphenhydramine hydrochloride

Dosage Form: kit for oral suspension
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.

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 NDC Product Code (Source) 43093-104

Packaging # NDC Package Description Multilevel Packaging 1 43093-104-01 1 KIT In 1 KIT None

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

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 0.75 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   Xylitol   GLYCYRRHIZIN, AMMONIATED   Pineapple   Xanthan Gum   Stevia Leaf   Orange   Citric Acid   Sodium Citrate   Melatonin   Potassium Sorbate   Sodium Benzoate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 150 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

More Dicopanol resources

• Dicopanol Side Effects (in more detail)
• Dicopanol Use in Pregnancy & Breastfeeding
• Dicopanol Drug Interactions
• Dicopanol Support Group
• 0 Reviews for Dicopanol - Add your own review/rating

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