DICOPANOL- diphenhydramine hydrochloride kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)

Available from:

Fusion Pharmaceuticals LLC

INN (International Name):

DIPHENHYDRAMINE HYDROCHLORIDE

Composition:

DIPHENHYDRAMINE HYDROCHLORIDE 0.75 g in 0.75 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

unapproved drug other

Summary of Product characteristics

DICOPANOL- DIPHENHYDRAMINE HYDROCHLORIDE
FUSION PHARMACEUTICALS LLC
_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._
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DICOPANOL
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)
Man