Zyrtec-D (Cetirizine Hydrochloride / Pseudoephedrine Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

ZYRTEC-D 12 HOUR Extended Release Tablets should be administered when both the antihistaminic properties of cetirizine hydrochloride and the nasal decongestant properties of pseudoephedrine hydrochloride are desired.

ZYRTEC-D 12 HOUR Extended Release Tablets are indicated for the relief of nasal and non-nasal symptoms associated with seasonal or perennial allergic rhinitis in adults and children 12 years of age and older.

DOSAGE AND ADMINISTRATION

Adults and Children 12 Years of Age and Older

The recommended dose of ZYRTEC-D 12 HOUR Extended Release Tablets is one tablet twice daily for adults and children 12 years of age and older. ZYRTEC-D 12 HOUR Extended Release Tablets may be given with or without food.

Dose Adjustment for Renal and Hepatic Impairment

In patients with decreased renal function (creatinine clearance 11–31 mL/min), patients on hemodialysis (creatinine clearance less than 7 mL/min), and in hepatically impaired patients, a dose of one tablet once daily is recommended (see CLINICAL PHARMACOLOGY and PRECAUTIONS).

ZYRTEC-D 12 HOUR Extended Release Tablets should be swallowed whole, and should not be broken or chewed.

HOW SUPPLIED

ZYRTEC-D 12 HOUR Extended Release Tablets are white, round, biconvex, bilayer tablets containing 5 mg cetirizine hydrochloride in an immediate release layer and 120 mg pseudoephedrine hydrochloride in an extended release layer. ZYRTEC-D 12 HOUR Extended Release Tablets are supplied in high-density polyethylene bottles of 100 tablets fitted with polypropylene child-resistant closures (NDC 0069-1630-66).

ZYRTEC-D 12 HOUR Extended Release Tablets are engraved with ZYRTEC-D on one side.

STORAGE

Store at 20–25°C (68–77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]

Rx only

Cetirizine is licensed from UCB Pharma, Inc.

Marketed by

LAB-0038-5.0