Dicopanol

Generic name:diphenhydramine hydrochloride
Dosage form: kit for oral suspension
Drug classes:Anticholinergic antiemetics, Anticholinergic antiparkinson agents, Antihistamines, Miscellaneous anxiolytics, sedatives and hypnotics

Medically reviewed by Drugs.com. Last updated on Oct 22, 2021.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

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)