FDA approved Zyrtec Allergy (cetirizine) for Hay Fever and Upper Respiratory Allergy SymptomsFDA approved new melt-in-mouth allergy drug Zyrtec Allergy.

FDA From the archive Source published September 3, 2010 Summary added July 7, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Note that Zyrtec Allergy is for temporary symptom relief; drowsiness may occur and alcohol/sedatives increase risk.

The FDA has approved Zyrtec Allergy (cetirizine) 10 mg orally disintegrating tablets for the temporary relief of symptoms due to hay fever or other upper respiratory allergies, including runny nose, sneezing, itchy watery eyes, and itching of the nose or throat. The product, which melts in the mouth and can be taken with or without water, offers an alternative formulation for patients who have difficulty swallowing pills. Clinicians should note that the dosing is once daily for adults and children 6 years and older, with a maximum of 10 mg in 24 hours. A 5 mg product may be appropriate for less severe symptoms. The label advises that patients aged 65 years and over, children under 6 years, and those with liver or kidney disease should consult a doctor before use.

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

Mechanism of Action

Not reported in label.

Indication & Patient Population

Zyrtec Allergy is indicated for the temporary relief of symptoms due to hay fever or other upper respiratory allergies: runny nose, sneezing, itchy watery eyes, itching of the nose or throat. It is for use in adults and children 6 years and over.

Dosing & Administration

The tablet melts in the mouth and can be taken with or without water. Adults and children 6 years and over: one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. Adults 65 years and over, children under 6 years of age, and consumers with liver or kidney disease should 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 or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product, drowsiness may occur; avoid alcoholic drinks; alcohol, sedatives, and tranquilizers may increase drowsiness; be careful when driving a motor vehicle or operating machinery. Stop use and ask a doctor if an allergic reaction to this product occurs; seek medical help right away. If pregnant or breast-feeding: if breast-feeding, 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 (1-800-222-1222).

Place in Therapy

Not reported in label.

The FDA has approved Zyrtec Allergy (cetirizine) 10 mg orally disintegrating tablets for temporary relief of hay fever or other upper respiratory allergy symptoms. These include runny nose, sneezing, itchy watery eyes, and itching of the nose or throat. The tablet melts in the mouth and can be taken with or without water. This offers an alternative for people who have difficulty swallowing pills.

Zyrtec Allergy is for adults and children 6 years and older. The recommended dose is one tablet once daily, with a maximum of 10 mg in 24 hours. A 5 mg dose may be used for less severe symptoms. The approval means patients now have a convenient, easy-to-take form of a well-known allergy medicine.

However, this is not a new drug. It is a new formulation of cetirizine, which has been available for years. Patients aged 65 and over, children under 6, and those with liver or kidney disease should talk to their doctor before using this product. Also, if you are pregnant or breastfeeding, consult your healthcare provider.

This approval gives patients more choices for managing allergy symptoms. But as with any medication, it is important to use it as directed and to discuss any concerns with your doctor. The drug is available over the counter, but reading the label carefully is always a good idea.

What this means for you:

Zyrtec Allergy melt-in-mouth tablets offer a new way to take a familiar allergy medicine, but talk to your doctor if you have health concerns.

Study Details

Study typeFda approval

PublishedSep 2010

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

FDA approved Zyrtec Allergy (cetirizine) for Hay Fever and Upper Respiratory Allergy SymptomsFDA approved new melt-in-mouth allergy drug Zyrtec Allergy.

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.

FDA approved Zyrtec Allergy (cetirizine) for Hay Fever and Upper Respiratory Allergy SymptomsFDA approved new melt-in-mouth allergy drug Zyrtec Allergy.

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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