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Home › Allergy & Immunology › FDA Approves Children's Claritin (loratadine) for Allergic Rhinitis Symptoms

FDA Approves Children's Claritin (loratadine) for Allergic Rhinitis Symptoms

FDA Approves Children's Claritin (loratadine) for Allergic Rhinitis Symptoms
Photo by Brett Jordan / Unsplash
FDA Published May 22, 2026 Medically reviewed May 22, 2026 DOI ↗ By Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease
Key Takeaway
Note the age-based dosing: 2 tablets daily for ages 6+, 1 tablet daily for ages 2-6.

The FDA has approved Children's Claritin (loratadine) chewable tablets for the temporary relief of symptoms due to hay fever or other upper respiratory allergies. The indication covers runny nose, itchy and watery eyes, sneezing, and itching of the nose or throat. This approval provides an over-the-counter option for pediatric patients aged 2 years and older. Clinicians should note that dosing differs by age: children 6 years and over should chew 2 tablets daily, while children 2 to under 6 years should chew 1 tablet daily. The product is not recommended for children under 2 years without a doctor's guidance. Patients with liver or kidney disease should consult a physician before use. The approval underscores the importance of appropriate dosing to avoid adverse effects such as drowsiness, which can occur with excessive intake.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Not reported in label.

Indication & Patient Population

Children's Claritin is indicated for temporary relief of symptoms due to hay fever or other upper respiratory allergies: runny nose, itchy/watery eyes, sneezing, itching of the nose or throat. It is for use in children 2 years and older.

Dosing & Administration

Chew or crush tablets completely before swallowing. Adults and children 6 years and over: chew 2 tablets daily; not more than 2 chewable tablets in 24 hours. Children 2 to under 6 years: chew 1 tablet daily; not more than 1 chewable tablet in 24 hours. Children under 2 years: ask a doctor. Consumers with liver or kidney disease: ask a doctor.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. Do not take more than directed; taking more may cause drowsiness. Stop use and ask a doctor if an allergic reaction occurs. If pregnant or breast-feeding, 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.

Study Details

Study typeFda approval
PublishedAug 2006
View Original Abstract ↓
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ●runny nose ●itchy, watery eyes ●sneezing ●itching of the nose or throat
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