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FDA approved Children's Zyrtec Allergy (cetirizine) for Symptoms of Upper Respiratory AllergiesFDA approved a chewable allergy medicine for children called Children's Zyrtec Allergy

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Key Takeaway
Note specific age-based dosing and warnings for drowsiness and use in renal/hepatic impairment.

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)
Mechanism of Action

Not reported in label.

Indication & Patient Population

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.

Dosing & Administration

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.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

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.

Place in Therapy

Not reported in label.

The U.S. Food and Drug Administration (FDA) has given its approval to a new chewable allergy medicine for kids. The medicine is called Children's Zyrtec Allergy, and it contains the active ingredient cetirizine. It is meant to give temporary relief from common allergy symptoms. These include a runny nose, sneezing, and itchy, watery eyes caused by things like hay fever or other seasonal allergies.

This approval is for a version made specifically for children as young as 2 years old. The chewable tablet form can be easier for kids to take than a pill. The official label also includes clear dosing information for adults and older patients. This makes it a flexible option for families.

The FDA's approval means this specific product has been reviewed for safety and effectiveness for its intended use. It provides a trusted, kid-friendly choice for managing allergy symptoms. However, it's important to remember that all medicines have considerations.

One key point for patients and parents is to talk with a doctor or pharmacist before starting any new medicine. This is especially important if the person taking it has liver or kidney issues, is under 2 years old, or is pregnant or breastfeeding. Having a conversation with your doctor helps ensure this medicine is the right choice for your specific situation.

What this means for you:
A chewable allergy medicine for kids is now officially approved, but talk to your doctor first.

Study Details

Study typeFda approval
PublishedMar 2004
View Original Abstract ↓
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
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