"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
Vituz® Oral Solution is indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older.
Important Limitations of Use
Not indicated for pediatric patients under 18 years of age [see Use In Specific Populations].
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.
5 mL of Vituz Oral Solution contains: hydrocodone bitartrate, USP, 5 mg and chlorpheniramine maleate, USP, 4 mg [see DESCRIPTION].
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., Madison, MS 39110 Vituz® Oral Solution is a Registered Trademark of Hawthorn Pharmaceuticals, Inc.
Last reviewed on RxList: 3/1/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Vituz Information
Report Problems to the Food and Drug Administration
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