FDA approved Xyzal Allergy 24hr (levocetirizine) for Hay Fever and Respiratory Allergy SymptomsFDA approved new over-the-counter allergy drug Xyzal Allergy 24hr

FDA From the archive Source published January 31, 2017 Summary added May 22, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Xyzal Allergy 24hr as an OTC option for allergic rhinitis symptoms, but avoid in patients with kidney disease and counsel about drowsiness.

The FDA has approved Xyzal Allergy 24hr (levocetirizine), an over-the-counter antihistamine, for temporary relief of symptoms due to hay fever or other respiratory allergies. The approval covers symptoms including runny nose, sneezing, itchy watery eyes, and itching of the nose or throat. This approval provides an additional OTC option for patients seeking relief from seasonal and perennial allergic rhinitis symptoms. Clinicians should note that the product is not recommended for patients with kidney disease and may cause drowsiness, advising caution with driving or operating machinery.

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

Mechanism of Action

Not reported in label.

Indication & Patient Population

Temporarily relieves these symptoms due to hay fever or other respiratory allergies: runny nose, sneezing, itchy watery eyes, itching of the nose or throat.

Dosing & Administration

Adults 65 years and older: ask a doctor. Adults and children 12-64 years: take 1 tablet (5 mg) once daily in the evening; do not take more than 1 tablet (5 mg) in 24 hours. Half tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms. Children 6-11 years: take half tablet (2.5 mg) once daily in the evening; do not take more than half tablet (2.5 mg) in 24 hours. Children under 6 years: do not use. Consumers with kidney disease: do not use.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Do not use if you have kidney disease or if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine. Ask a doctor before use if you have ever had trouble urinating or emptying your bladder. 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 you have trouble urinating or emptying your bladder or if an allergic reaction 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 Xyzal Allergy 24hr (levocetirizine) as an over-the-counter medicine for temporary relief of symptoms caused by hay fever or other respiratory allergies. These symptoms include runny nose, sneezing, itchy watery eyes, and itching of the nose or throat. This approval provides a new option for people who want to manage their allergy symptoms without a prescription.

Xyzal Allergy 24hr is for adults and children ages 6 and older. It is not recommended for people with kidney disease. Like some other antihistamines, it can cause drowsiness. Patients should be careful when driving or using machinery until they know how the medicine affects them.

This approval means patients now have another choice for treating seasonal and year-round allergy symptoms. However, it is important to talk to your doctor before starting any new medicine, especially if you have other health conditions or take other medications. Your doctor can help you decide if this product is right for you.

What this means for you:

Xyzal Allergy 24hr is a new OTC option for allergy relief, but may cause drowsiness.

Study Details

Study typeFda approval

PublishedJan 2017

View Original Abstract ↓

Uses temporarily relieves these symptoms due to hay fever or other respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

FDA approved Xyzal Allergy 24hr (levocetirizine) for Hay Fever and Respiratory Allergy SymptomsFDA approved new over-the-counter allergy drug Xyzal Allergy 24hr

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 Xyzal Allergy 24hr (levocetirizine) for Hay Fever and Respiratory Allergy SymptomsFDA approved new over-the-counter allergy drug Xyzal Allergy 24hr

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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