"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.
[See FDA-Approved Patient Labeling]
Patients should be advised not to increase the dose or dosing frequency of REZIRA Oral Solution because serious adverse events such as respiratory depression may occur with overdosage [see WARNINGS AND PRECAUTIONS; OVERDOSAGE].
Patients should be advised to measure REZIRA Oral Solution with an accurate milliliter measuring device. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is measured. Patients should be advised to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose [see DOSING AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].
Concomitant Use of Alcohol and Other Central Nervous System Depressants
Patients should be advised to avoid the use of alcohol and other central nervous system depressants while taking REZIRA Oral Solution because additional reduction in mental alertness may occur [see WARNINGS AND PRECAUTIONS].
Activities Requiring Mental Alertness
Patients should be advised to avoid engaging in hazardous tasks that require mental alertness and motor coordination such as operating machinery or driving a motor vehicle as REZIRA Oral Solution may produce marked drowsiness [see WARNINGS AND PRECAUTIONS].
Patients should be cautioned that REZIRA Oral Solution contains hydrocodone bitartrate and can produce drug dependence [see WARNINGS AND PRECAUTIONS].
Patients should be informed that due to its pseudoephedrine component, they should not use REZIRA Oral Solution with an MAOI or within 14 days of stopping the use of an MAOI [see WARNINGS AND PRECAUTIONS].
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
- Rezira Drug Interactions Center: pseudoephedrine-hydrocodone oral
- Rezira Side Effects Center
- Rezira FDA Approved Prescribing Information including Dosage
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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