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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.
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.
Additional Rezira Information
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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