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Rezira

"Common colds are the main reason that children miss school and adults miss work. Each year in the United States, there are millions of cases of the common cold. Adults have an average of 2-3 colds per year, and children have even more.

Most"...

Rezira

INDICATIONS

Common Cold

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].

DOSAGE AND ADMINISTRATION

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].

Adults 18 years of age and Older

5 mL every 4 to 6 hours as needed, not to exceed 4 doses (20 mL) in 24 hours.

HOW SUPPLIED

Dosage Forms And Strengths

REZIRA is a clear, colorless to light yellow, grape-flavored liquid.

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

Storage And Handling

REZIRA Oral Solution is supplied as a clear, colorless to light yellow, grape-flavored solution containing 5 mg hydrocodone bitartrate and 60 mg pseudoephedrine hydrochloride in each 5 mL. It is available in:

White HDPE bottles of one pint (480 mL): NDC 63717-875-16

Store solution at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure.

Manufactured for: Hawthorn Pharmaceuticals, Inc., Madison, MS 39110. Revised: May 2011

Last reviewed on RxList: 8/2/2011
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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