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FDA approved Children's Zyrtec Hives (cetirizine) for Hives ReliefFDA approved Children's Zyrtec Hives for itching and hives relief.

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Key Takeaway
Note: Children's Zyrtec Hives relieves hives and itching but does not prevent hives or allergic reactions.

The FDA has approved Children's Zyrtec Hives (cetirizine) for the relief of hives and associated itching. The product is indicated for reducing hives (urticaria) and relieving itching due to hives, but it will not prevent hives or allergic skin reactions from occurring. Clinicians should note that the approval is based on the established efficacy of cetirizine for this indication; specific clinical trial data are not included in the label. The approval provides an additional over-the-counter option for symptomatic management of hives in patients aged 6 years and older. Dosing recommendations vary by age and severity, with a maximum daily dose of 10 mL for adults and children 6 years and over, and 5 mL for adults 65 years and over. The label includes warnings about severe allergic reactions and emphasizes that the product is not a substitute for epinephrine in patients with anaphylaxis.

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

Not reported in label.

Indication & Patient Population

Children's Zyrtec Hives is indicated for reducing hives and relieving itching due to hives (urticaria). It is not intended to prevent hives or an allergic skin reaction from occurring. The product is for use in adults and children 6 years and over. Adults 65 years and over should use a reduced dose. Children under 6 years of age should ask a doctor before use.

Dosing & Administration

Use only with the enclosed dosing cup. Find the right dose on the chart below; mL = milliliter. Adults and children 6 years and over: 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. Adults 65 years and over: 5 mL once daily; do not take more than 5 mL in 24 hours. Children under 6 years of age: ask a doctor. Consumers with liver or kidney disease: ask a doctor.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms: trouble swallowing, dizziness or loss of consciousness, swelling of tongue, swelling in or around mouth, trouble speaking, drooling, wheezing or problems breathing. These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later. Not a Substitute for Epinephrine: If your doctor has prescribed an epinephrine injector for anaphylaxis or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times. Do not use: to prevent hives from any known cause such as foods, insect stings, medicines, latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. 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, hives that are an unusual color, look bruised or blistered, or hives that do not itch. 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), symptoms do not improve after 3 days of treatment, or the hives have lasted more than 6 weeks. 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

Children's Zyrtec Hives provides an over-the-counter option for symptomatic relief of hives and itching in appropriate patients. It is not a preventive treatment and should not replace epinephrine in patients with anaphylaxis risk. Clinicians should counsel patients on proper use and when to seek medical attention.

The FDA has approved a new over-the-counter medicine called Children's Zyrtec Hives. It contains cetirizine, an antihistamine that helps relieve hives and the itching they cause. This product is for people ages 6 years and older. It works by reducing the symptoms of hives, but it will not stop hives from happening in the first place.

This approval gives families another option for managing hives at home. The medicine comes in a liquid form. Adults and children 6 years and older can take up to 10 mL per day. Adults 65 years and older should take no more than 5 mL per day. Always follow the dosing instructions on the label.

It is important to know that this product is not a treatment for severe allergic reactions like anaphylaxis. If you have a history of severe allergies, you should keep your epinephrine auto-injector available. Children's Zyrtec Hives is not a substitute for emergency care.

If you are unsure whether this medicine is right for you or your child, talk to your doctor or pharmacist. They can help you understand how it fits into your allergy management plan. This approval adds a helpful tool, but it does not replace medical advice or emergency treatments.

What this means for you:
Children's Zyrtec Hives relieves hives and itching but does not prevent them or treat severe allergic reactions.

Study Details

Study typeFda approval
PublishedNov 2007
View Original Abstract ↓
Uses reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
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