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].

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.

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.