a lot of Dicopanol Generic Name: diphenhydramine hydrochloride Dosage Form: kit for oral suspension Side Effects Dosage Professional Interactions Pregnancy More Breastfeeding Warnings User Reviews Support Group Q & A 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. 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 Slideshow Seasoned Pro: Be Mindful of These Winter Health Hazards 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) 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 Dicopanol diphenhydramine hydrochloride kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43093-104 Packaging # Item Code Package Description 1 NDC:43093-104-01 1 KIT 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 suspension Product Information Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 0.75 g in 0.75 g Packaging # Item Code Package Description 1 0.75 g in 1 BOTTLE, GLASS 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 liquid Product Information Route of Administration ORAL DEA Schedule Inactive Ingredients Ingredient Name Strength WATER GLYCERIN XYLITOL GLYCYRRHIZIN, AMMONIATED PINEAPPLE XANTHAN GUM STEVIA LEAF ORANGE CITRIC ACID MONOHYDRATE SODIUM CITRATE MELATONIN POTASSIUM SORBATE SODIUM BENZOATE Packaging # Item Code Package Description 1 150 mL in 1 BOTTLE, PLASTIC 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 Operations California Pharmaceuticals LLC 021420944 manufacture(43093-104) Revised: 11/2015 Fusion Pharmaceuticals LLC Next Interactions Print this page Add to My Med List More about Dicopanol (diphenhydramine) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: anticholinergic antiemetics Consumer resources Professional resources Diphenhydramine Hydrochloride (AHFS Monograph) Diphenhydramine Oral Solution (FDA) Other brands: Benadryl , Benadryl Children's Allergy Related treatment guides Allergic Reactions Allergic Rhinitis Cold Symptoms Cough ... +5 more FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Drug Class Anticholinergic antiemetics Anticholinergic antiparkinson agents Antihistamines Miscellaneous anxiolytics, sedatives and hypnotics Related Drugs anticholinergic antiemetics meclizine , diphenhydramine , Benadryl , Antivert , scopolamine , Transderm-Scop anticholinergic antiparkinson agents diphenhydramine , Benadryl , benztropine , Cogentin , trihexyphenidyl , Banophen antihistamines loratadine , cetirizine , Zyrtec , hydroxyzine , Claritin , promethazine miscellaneous anxiolytics, sedatives and hypnotics zolpidem , Ambien , hydroxyzine , melatonin , buspirone , diphenhydramine Allergic Reactions prednisone , promethazine , loratadine , triamcinolone , diphenhydramine , Benadryl , More... Cold Symptoms diphenhydramine , Benadryl , Promethazine DM , chlorpheniramine , echinacea , Tussionex Pennkinetic , More... Allergic Rhinitis prednisone , Zyrtec , promethazine , fluticasone nasal , loratadine , cetirizine , More... 6 more conditions... Dicopanol Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! common
condo Dicopanol is trying
EmoticonEmoticon