Dicopanol
Product Images NDC 43093-104

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Dicopanol (NDC 43093-104). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Fusion Pharmaceuticals Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Diphenhydramine Label (Cs65 A1 Rev 1)

This is a medication containing Diphenhydramine Hydrochloride. The safety seal should not be used if it is broken. It is RX only and repackaged by Fusion Pharmaceuticals. The Net contents are 0.75 g. The rest of the text appears to be chemical and company information.*

FDA Label Image

Suspension Label (Cs66 A1 Rev 1)

This is an oral suspension vehicle that is free from sugar, dye and paraben. It contains various ingredients such as water, glycerin, xylitol, pineapple flavor, xanthan gum, stevia powder, orange flavor, citric acid, sodium citrate, melatonin, potassium sorbate, and sodium benzoate. It is important not to use the product if the safety seal is broken. The net contents of the product is 150 mL (5.1 fl oz) and it is manufactured for Fusion Pharmaceuticals, LLC located in Camarillo, CA.*

FDA Label Image

Insert Page 1 (Cs67 A1 Rev 1 Page 1)

The FusePaqT DICOPANOL kit is a pre-measured set of active and inactive bulk materials that can be used to rapidly create prescription medications, specifically an oral suspension containing diphenhydramine hydrochloride at a strength defined by the prescriber. The kit contains 0.75 g of diphenhydramine hydrochloride and a 150 mL oral suspension vehicle with various flavorings and additives, as well as an oral dispenser and instructions. The kit is manufactured according to US FDA cGMP standards. Pharmacist should inspect the contents, wear gloves and eye protection, and combine the contents of the kit as per the instructions.*

FDA Label Image

Insert Page 2 (Cs67 A1 Rev 1 Page 2)

This text describes the instructions for pharmacists to prepare an oral suspension of diphenhydramine hydrochloride using FusePaq ik DICOPANOL™ suspension liquid. The process involves transferring the liquid to the diphenhydramine hydrochloride bottle, shaking it well, and emptying the contents back into the suspension bottle multiple times to ensure all of the powder is dissolved. Once complete, the resulting final suspension must be labeled and stored at room temperature. The kit includes an oral dispenser for administering the suspension. The stability of the final suspension has been confirmed through testing, and the manufacturer is Fusion Pharmaceuticals, LLC.*

FDA Label Image

Dicopanol Box (Cs68 A1 Rev 2)

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.