DICOPANOL
-
diphenhydramine hydrochloride
Fusion Pharmaceuticals LLC
----------
DICOPANOLDo 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:
Inactive Ingredients:
For Prescription Compounding Only
U.S. Patents Pending
CS68-A1 rev 0
Do not use if safety seal is broken
For Prescription Compounding Only
Diphenhydramine Hydrochloride
Ethanamine, 2-(diphenylmethoxy)-N,N-dimethyl-, hydrochlorideNet contents: 0.75 g
Repackaged by:
Fusion Pharmaceuticals, LLC
Camarillo, CA 93012
CS65-A1 rev 0
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
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:
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 |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
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 |