FDA Approves Xyzal Allergy 24hr (levocetirizine) for Hay Fever and Respiratory Allergy Symptoms
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)
Not reported in label.
Temporarily relieves these symptoms due to hay fever or other respiratory allergies: runny nose, sneezing, itchy watery eyes, itching of the nose or throat.
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.
Trial data not available in label.
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).
Not reported in label.
View Original Abstract ↓
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