DICOPANOL- diphenhydramine hydrochloride kit

Dicopanol by

Drug Labeling and Warnings

Dicopanol by is a Prescription medication manufactured, distributed, or labeled by Fusion Pharmaceuticals LLC, California Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Principal Display Panel

Do not use if safety seal is broken

NDC: 43093-104-01

Rx only

FusePaq™   Oral Suspension Kit

DICOPANOL™

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

Description:
This kit contains active and inactive bulk materials to prepare 150 mL of a  diphenhydramine hydrochloride oral suspension containing 5 mg/mL diphenhydramine hydrochloride. This kit may only be used for the extemporaneous combining of these ingredients by an appropriate licensed medical professional in response to a physician's prescription to create a medication tailored to the specialized needs of an individual patient.
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

Store kit at room temperature, 15-30 degrees C (59-86 degrees F)

U.S. Patents Pending   FUSION PHARMACEUTICALS   786 Calle Plano  Camarillo CA 93012

CS68-A1 rev 2

Drug Label

Do not use if safety seal is broken

Diphenhydramine Hydrochloride
Ethanamine, 2-(diphenylmethoxy)-N,N-dimethyl-, hydrochloride

Rx Only

CAS# 147-24-0

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

CS65-A1 rev 1

Suspension Label

Do not use if safety seal is broken

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 1

Instructions Insert

NDC: 43093-104-01
Rx Only

FusePaq tm  DICOPANOL tm
(diphenhydramine hydrochloride 5 mg/mL, oral suspension- kit)

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

Description:

This kit contains active and inactive bulk materials to create a diphenhydramine hydrochloride oral suspension. These instructions describe how to prepare 150 mL of oral suspension containing 5 mg/mL diphenhydramine hydrochloride. Other concentrations are possible. Exact strength of the resulting final 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)


Instructions for the Pharmacist

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 Combining

Wear gloves and eye protection during combining 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 combine 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 Combining Process

Insert the press-in bottle adaptor into the suspension bottle. Recap the suspension bottle. Shake well by inverting repeatedly several times.


5    Re-label the Resulting Final Suspension

Label the resulting final suspension per the pharmacy's standard practice. Remove or obscure the oral suspension vehicle label, since the label is no longer accurate once the resulting final suspension is completed.


Store the unused kit at room temperature of 15-30°C (59-86°F). Once prepared, store the resulting final suspension between 15-30°C (59-86°F). The resulting final 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 1

INGREDIENTS AND APPEARANCE

DICOPANOL 
diphenhydramine hydrochloride kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 43093-104

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43093-104-01	1 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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	0.75 g  in 0.75 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.75 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
GLYCYRRHIZIN, AMMONIATED (UNII: 3VRD35U26C)
PINEAPPLE (UNII: 2A88ZO081O)
XANTHAN GUM (UNII: TTV12P4NEE)
STEVIA LEAF (UNII: 6TC6NN0876)
ORANGE (UNII: 5EVU04N5QU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
MELATONIN (UNII: JL5DK93RCL)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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)

Registrant - Fusion Pharmaceuticals LLC (021420944)

Establishment
Name	Address	ID/FEI	Business Operations
California Pharmaceuticals LLC		021420944	manufacture(43093-104)