March 26, 2017
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(hydrocodone bitartrate and pseudoephedrine hydrochloride) Oral Solution


REZIRA Oral Solution contains hydrocodone bitartrate (a semisynthetic centrally-acting opioid antitussive) and pseudoephedrine hydrochloride (a sympathomimetic amine).

Each 5 mL dose of REZIRA Oral Solution contains: hydrocodone bitartrate, USP, 5 mg; and pseudoephedrine hydrochloride, USP, 60 mg.

REZIRA Oral Solution also contains: citric acid anhydrous, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sodium saccharin, and sucrose.

Hydrocodone bitartrate is morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5α)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5); also known as 4,5α-Epoxy-3- methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5); a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine; and may be represented by the following structural formula:

Hydrocodone bitartrate - Structural Formula Illustration

Pseudoephedrine hydrochloride is benzenemethanol, α-[1-(methylamino)ethyl]-, [S-(R*,R*)] hydrochloride and has the following chemical structure:

Pseudoephedrine hydrochloride - Structural Formula Illustration

Last reviewed on RxList: 4/8/2016
This monograph has been modified to include the generic and brand name in many instances.

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