(diphenhydramine hydrochloride 5 mg/mL, in oral suspension kit)
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.
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).
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.
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
Fusion Pharmaceuticals, LLC
768 Calle Plano
Camarillo, CA 93012
CS67-A1 rev 1
Dicopanol diphenhydramine hydrochloride kit
HUMAN PRESCRIPTION DRUG LABEL
Item Code (Source)
1 KIT (KIT) in 1 KIT
Quantity of Parts
Total Product Quantity
1 BOTTLE, GLASS
1 BOTTLE, PLASTIC
Part 1 of 2
DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride powder, for suspension
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