Rezira
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
REZIRA® Oral Solution (hydrocodone bitartrate and pseudoephedrine hydrochloride) is indicated for:
Relief of cough and nasal congestion associated with common cold.
Important Limitations of Use:
Not indicated for pediatric patients under 18 years of age [see Pediatric Use (8.4)].
History
There is currently no drug history available for this drug.
Other Information
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:
Pseudoephedrine hydrochloride is benzenemethanol, α-[1-(methylamino)ethyl]-, [S-(R*,R*)] hydrochloride and has the following chemical structure:
Sources
Rezira Manufacturers
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Hawthorn Pharmaceuticals, Inc.
![Rezira (Hydrocodone Bitartrate, Pseudoephedrine Hydrochloride) Solution [Hawthorn Pharmaceuticals, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Rezira | Hawthorn Pharmaceuticals, Inc.
Administer REZIRA Oral Solution by the oral route only. Measure REZIRA Oral Solution with an accurate milliliter measuring device. Do not use a household teaspoon to measure the dose [see Warnings and Precautions (5.9)].
2.1 Adults 18 Years of Age and Older5 mL every 4 to 6 hours as needed, not to exceed 4 doses (20 mL) in 24 hours.
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