Label: DICOPANOL- diphenhydramine hydrochloride kit
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Contains inactivated NDC Code(s)
NDC Code(s): 43093-104-01 - Packager: Fusion Pharmaceuticals LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated November 19, 2015
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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
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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
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INGREDIENTS AND APPEARANCE
DICOPANOL
diphenhydramine hydrochloride kitProduct 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 suspensionProduct 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 liquidProduct 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)