FDA Approves Children's Zyrtec Allergy (cetirizine) for Symptoms of Upper Respiratory Allergies
The FDA has approved Children's Zyrtec Allergy (cetirizine) chewable tablets for the temporary relief of symptoms due to hay fever or other upper respiratory allergies. The approval, dated March 16, 2004, covers symptoms including runny nose, sneezing, and itchy, watery eyes. This provides a pediatric-appropriate formulation of the second-generation antihistamine cetirizine for children as young as 2 years, with specific dosing guidance also provided for adults and patients 65 years and older. The label includes standard warnings regarding drowsiness and interactions with CNS depressants, and advises consultation with a doctor for patients with liver or kidney disease, those under 2 years of age, and pregnant or breastfeeding individuals.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Not reported in label.
Indicated to temporarily relieve symptoms due to hay fever or other upper respiratory allergies: runny nose, sneezing, itchy, watery eyes, itching of the nose or throat.
Tablets are chewable and may be taken with or without water; they must be chewed or crushed completely before swallowing. For children 2 to under 6 years: 1 tablet (2.5 mg) once daily; dose can be increased to a maximum of 2 tablets (5 mg) once daily or 1 tablet (2.5 mg) every 12 hours. Do not exceed 2 tablets (5 mg) in 24 hours. For adults and children 6 years and over: 2 tablets (5 mg) or 4 tablets (10 mg) once daily depending on symptom severity; do not exceed 4 tablets (10 mg) in 24 hours. For adults 65 years and over: 2 tablets (5 mg) once daily; do not exceed 2 tablets (5 mg) in 24 hours. For children under 2 years, consumers with liver or kidney disease: ask a doctor.
Trial data not available in label.
Contraindicated in patients who have ever had an allergic reaction to this product, any of its ingredients, or to an antihistamine containing hydroxyzine. Ask a doctor before use if the patient has liver or kidney disease, as a different dose may be needed. Ask a doctor or pharmacist before use if taking tranquilizers or sedatives. Drowsiness may occur; avoid alcoholic drinks as alcohol, sedatives, and tranquilizers may increase drowsiness. Be careful when driving or operating machinery. Stop use and ask a doctor if an allergic reaction occurs; seek medical help right away. If pregnant or breastfeeding: if breastfeeding, use is not recommended; if pregnant, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Not reported in label.