Xyzal is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms such as a runny nose or hives.

Xyzal is used to treat symptoms of year-round (perennial) allergies in children who are at least 6 months old.

Xyzal is also used to treat itching and swelling caused by chronic urticaria (hives) in adults and children who are at least 6 months old.

Before taking Xyzal, tell your doctor if you have liver disease, kidney disease, or gallbladder problems.

It is very important not to give a child more than the prescribed dose of Xyzal. A child's body absorbs twice as much of the same dose size of levocetirizine as an adult's body.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever.

Before taking this medicine

You should not use Xyzal if you are allergic to levocetirizine or cetirizine (Zyrtec).

You should not take Xyzal if you have end-stage kidney disease or if you are on dialysis. Any child younger than 12 years old with kidney disease should not take levocetirizine.

Tell your doctor if you have ever had:

• kidney disease;

• liver disease;

• urination problems (caused by conditions such as enlarged prostate or spinal cord lesion); or

• gallbladder problems.

Levocetirizine is not expected to harm an unborn baby. Tell your doctor if you are pregnant.

You should not breast-feed while using this medicine.

Xyzal is not approved for use by anyone younger than 6 months old.

Take Xyzal exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

A child's dose of levocetirizine is based on the age of the child. Follow your doctor's dosing instructions very carefully.

Do not give a child more than the prescribed dose of this medicine. A child's body absorbs twice as much of the same dose size of levocetirizine as an adult's body.

Taking more of this medication will not make it more effective, and may cause severe drowsiness.

Xyzal is usually taken in the evening, with or without food.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Urticaria:

5 mg orally once a day in the evening

Comments: Some patients may be adequately controlled on 2.5 mg orally once a day in the evening.

Use: For the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria

Usual Adult Dose for Allergic Rhinitis:

Seasonal Allergic Rhinitis (OTC): 5 mg orally once a day in the evening; some patients may be adequately controlled on 2.5 mg once a day

Usual Pediatric Dose for Allergic Rhinitis:

Perennial Allergic Rhinitis:
6 months to 2 years: 1.25 mg orally once a day in the evening

Comments: The recommended dose in pediatric patients 6 months to 2 years should not be exceeded.

Use: For the relief of symptoms associated with perennial allergic rhinitis

Seasonal Allergic Rhinitis (OTC):
6 to 11 years: 2.5 mg orally once a day in the evening
12 years or older: 5 mg orally once a day in the evening; some patients may be adequately controlled on 2.5 mg once a day

Comments: Avoid use in patients less than 6 years.

Usual Pediatric Dose for Urticaria:

6 months to 5 years: 1.25 mg orally once a day in the evening
6 to 11 years: 2.5 mg orally once a day in the evening
12 years or older: 5 mg orally once a day in the evening; some patients may be adequately controlled on 2.5 mg once a day

Comments: The recommended doses in pediatric patients 6 months to 12 years should not be exceeded.

Use: For the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria

You should not use Xyzal if you are allergic to levocetirizine or cetirizine (Zyrtec).

You should not take Xyzal if you have end-stage kidney disease or if you are on dialysis. Any child younger than 12 years old with kidney disease should not take levocetirizine.

Tell your doctor if you have ever had:

• kidney disease;

• liver disease;

• urination problems (caused by conditions such as enlarged prostate or spinal cord lesion); or

• gallbladder problems.

Levocetirizine is not expected to harm an unborn baby. Tell your doctor if you are pregnant.

You should not breast-feed while using this medicine.

Xyzal is not approved for use by anyone younger than 6 months old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Drinking alcohol with this medicine can cause side effects.

Get emergency medical help if you have signs of an allergic reaction to Xyzal: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• worsening allergy or urticaria symptoms;

• painful or difficult urination;

• little or no urination;

• a light-headed feeling, like you might pass out;

• fever; or

• signs of an ear infection - ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child.

Common Xyzal side effects may include:

• drowsiness, tiredness;

• sinus pain;

• ear infection;

• cough;

• fever;

• nosebleed;

• vomiting, diarrhea, constipation;

• dry mouth; or

• weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using Xyzal with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• ritonavir; or

• theophylline.

This list is not complete. Other drugs may interact with levocetirizine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.