FDA records indicate that there are no current recalls for this drug.
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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
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
ZUTRIPRO® Oral Solution is indicated for relief of cough and nasal congestion associated with the common cold in adults 18 years of age and older.
ZUTRIPRO® Oral Solution is indicated for relief of symptoms including nasal congestion associated with upper respiratory allergies in adults 18 years of age and older.
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
ZUTRIPRO® Oral Solution contains hydrocodone bitartrate (a semisynthetic centrally-acting opioid antitussive), chlorpheniramine maleate (an antihistamine), and pseudoephedrine hydrochloride (indirect sympathomimetic amine).
Each 5 mL dose of ZUTRIPRO® Oral Solution contains: hydrocodone bitartrate, USP, 5 mg; chlorpheniramine maleate, USP, 4 mg; and pseudoephedrine hydrochloride, USP, 60 mg.
ZUTRIPRO® 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:
Chlorpheniramine maleate is 2-pyridinepropanamine, γ-(4-chlorophenyl)-N,N-dimethyl-, (Z)-2-butenedioate (1:1) and has the following chemical structure:
Pseudoephedrine hydrochloride is benzenemethanol, α-[1-(methylamino)ethyl]-, [ S-(R*,R*)] hydrochloride and has the following chemical structure:
Sources
Zutripro Manufacturers
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Hawthorn Pharmaceuticals, Inc.
Zutripro | Hawthorn Pharmaceuticals, Inc.
Administer ZUTRIPRO® Oral Solution by the oral route only. Measure ZUTRIPRO® 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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