June 30, 2015
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Vituz

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Vituz

Indications
Dosage
How Supplied

INDICATIONS

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.

HOW SUPPLIED

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.

Indications
Dosage
How Supplied

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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