Aller-Ease is an antihistamine that is used to treat the symptoms of seasonal allergies (hay fever) in adults and children.

Aller-Ease is also used to treat skin itching and hives caused by a condition called chronic idiopathic urticaria in adults and children at least 6 years old.

There are many brands and forms of fexofenadine available. Not all brands are listed on this leaflet.

Aller-Ease may also be used for purposes not listed in this medication guide.

Do not take Aller-Ease with fruit juice (such as apple, orange, or grapefruit).

Use exactly as directed on the label, or as prescribed by your doctor.

Always follow directions on the medicine label about giving cough or cold medicine to a child.

• Ask a doctor before giving Aller-Ease liquid to a child younger than 2 years old.

• The disintegrating (melting) tablets are not for use in a child younger than 6 years old.

• The 12-hour and 24-hour forms of Aller-Ease are not for use in a child younger than 12 years old.

Take this medicine only with water.

Take the disintegrating tablet on an empty stomach.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing cup provided, or use a medicine dose-measuring device (not a kitchen spoon).

Remove an orally disintegrating tablet from the package only when you are ready to take the medicine. Place the tablet on your tongue and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves.

Call your doctor if your symptoms do not improve, or if they get worse.

Store Aller-Ease in its original package at room temperature, away from moisture and heat. Do not allow liquid medicine to freeze.

You should not use Aller-Ease if you are allergic to it.

Ask a doctor or pharmacist if Aller-Ease is safe to use if you have:

• kidney disease.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

Older adults may be more sensitive to the effects of this medicine. If you are 65 or older, ask a doctor before taking Aller-Ease.

This medicine may contain phenylalanine and could be harmful if you have phenylketonuria (PKU).

Aller-Ease is used when needed. If you are on a dosing schedule, skip any missed dose. Do not use two doses at one time.

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

Overdose symptoms may include dry mouth, dizziness, or drowsiness.

Do not take Aller-Ease with fruit juice (such as apple, orange, or grapefruit). These juices can make it harder for your body to absorb this medicine.

Avoid taking an antacid within 2 hours before or after you take Aller-Ease. This medicine should not be used at the same time as antacids that contain magnesium or aluminum.

Ask a doctor or pharmacist before using other cough or cold medicines that may contain similar ingredients.

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

Aller-Ease may cause serious side effects. Stop using Aller-Ease and call your doctor at once if you have:

• flu-like symptoms (fever, chills, unusual tiredness);

• new or worsening cough;

• pain; or

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

Common side effects of Aller-Ease may include:

• headache;

• back pain; or

• cold symptoms such as stuffy nose, sinus pain, sore throat.

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 Aller-Ease 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.

Ask a doctor or pharmacist before using Aller-Ease with any other medications, especially:

• ketoconazole; or

• erythromycin.

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