"The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended restricting the use of codeine for cough and cold in children because there is a risk for serious adverse effects, including respiratory"...
Cough And Upper Respiratory Allergy Symptoms
Important Limitations Of Use
DOSAGE AND ADMINISTRATION
Administer Vituz Oral Solution by the oral route only. Measure Vituz 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
Vituz is a clear, colorless to light yellow, grape-flavored liquid.
Storage And Handling
Vituz Oral Solution is supplied as a clear, colorless to light yellow, grape-flavored solution containing 5 mg hydrocodone bitartrate and 4 mg chlorpheniramine maleate in each 5 mL. It is available in:
White HDPE bottles of one pint (480 mL): NDC 63717-877-16
Store solution at 20° to 25°C (68° to 77°F). [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., Morristown, NJ 07960. Revised: Sep 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/8/2016
Additional Vituz 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.
Find out what women really need.