FDA approved Claritin (loratadine) for Hay Fever and Upper Respiratory Allergy SymptomsFDA approved Claritin for Hay Fever and Allergy Symptom Relief

FDA From the archive Source published April 12, 1993 Summary added September 29, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Note: Claritin is dosed once daily for allergic rhinitis symptoms in patients 12 years and older.

The FDA has approved Claritin for the temporary relief of symptoms associated with hay fever or other upper respiratory allergies. The approved indication covers runny nose, itchy watery eyes, sneezing, and itching of the nose or throat. The product is indicated for adults and children 12 years and older, with a recommended dose of one tablet daily, not to exceed one tablet in 24 hours.

For clinicians, this approval adds a once-daily oral antihistamine for seasonal and perennial allergic rhinitis symptoms. The label advises patients with liver or kidney disease to ask a doctor before use, as a different dose may be needed. Patients should not exceed the recommended dose because taking more than directed may cause drowsiness. If an allergic reaction occurs, patients should stop use and seek medical help right away. Pregnant or breast-feeding individuals should consult a health professional before use. Clinical trial data are not available in the label.

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

Mechanism of Action

Not reported in label.

Indication & Patient Population

Temporarily relieves symptoms due to hay fever or other upper respiratory allergies: runny nose, itchy watery eyes, sneezing, itching of the nose or throat. Adults and children 12 years and older. Children under 6 years of age: ask a doctor. Consumers with liver or kidney diseases: ask a doctor.

Dosing & Administration

Adults and children 12 years and older: 1 tablet daily; not more than 1 tablet in 24 hours. Children under 6 years of age: ask a doctor. Consumers with liver or kidney diseases: 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; your doctor should determine if you need a different dose. When using this product, do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. 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.

Claritin is a once-daily oral medicine approved by the FDA to temporarily relieve symptoms of hay fever and other upper respiratory allergies. It helps with runny nose, itchy watery eyes, sneezing, and itching of the nose or throat. The approval covers adults and children 12 years and older.

The recommended dose is one tablet daily, and you should not take more than one tablet in 24 hours. Taking more than directed may cause drowsiness. People with liver or kidney disease should ask a doctor before use, because a different dose may be needed. Pregnant or breast-feeding individuals should also consult a health professional first.

This approval adds another option for people dealing with seasonal or year-round allergy symptoms. It offers a simple once-daily routine for many patients. However, it is not a cure for allergies, and it may not work the same for everyone.

If you have allergies, talk with your doctor or pharmacist about whether Claritin is right for you. If an allergic reaction occurs, stop use and seek medical help right away.

What this means for you:

Claritin is now FDA approved for allergy relief in adults and children 12 and older. Ask your doctor if it is right for you.

Study Details

Study typeFda approval

PublishedApr 1993

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

FDA approved Claritin (loratadine) for Hay Fever and Upper Respiratory Allergy SymptomsFDA approved Claritin for Hay Fever and Allergy Symptom Relief

Study Details

Budesonide-glycopyrronium-formoterol fumarate dihydrate improved lung function and reduced severe exacerbations versus budesonide-formoterol in inadequately controlled asthma

New Asthma Drug Cuts Attacks Without Recent Crisis

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FDA approved Claritin (loratadine) for Hay Fever and Upper Respiratory Allergy SymptomsFDA approved Claritin for Hay Fever and Allergy Symptom Relief

Study Details

Budesonide-glycopyrronium-formoterol fumarate dihydrate improved lung function and reduced severe exacerbations versus budesonide-formoterol in inadequately controlled asthma

New Asthma Drug Cuts Attacks Without Recent Crisis

Clinical research that matters. Delivered to your inbox.

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