Fexofenadine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Fexofenadine HCl-Pseudoephedrine 12 Hour is a combination medicine used to treat sneezing, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Fexofenadine HCl-Pseudoephedrine 12 Hour may also be used for purposes not listed in this medication guide.

Do not use Fexofenadine HCl-Pseudoephedrine 12 Hour if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold or allergy medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Take Fexofenadine HCl-Pseudoephedrine 12 Hour on an empty stomach, at least 1 hour before or 2 hours after a meal.

Take Fexofenadine HCl-Pseudoephedrine 12 Hour only with water. Avoid fruit juice; especially orange, apple, or grapefruit juice. Fruit juice can make it harder for your body to absorb fexofenadine.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cold or allergy medicine within the past few days.

Store at room temperature away from moisture and heat.

Do not use Fexofenadine HCl-Pseudoephedrine 12 Hour if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

• kidney disease;

• glaucoma;

• heart disease or high blood pressure;

• diabetes;

• thyroid disorder; or

• bladder obstruction or other urination problems.

It is not known whether Fexofenadine HCl-Pseudoephedrine 12 Hour will harm an unborn baby. Ask a doctor before using this medicine if you are pregnant.

Pseudoephedrine can pass into breast milk and may cause side effects in the nursing baby. Ask a doctor before using this medicine if you are breast-feeding.

Do not give this medicine to a child without medical advice.

Since cold or allergy medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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

Avoid using antacids within 15 minutes before or after taking Fexofenadine HCl-Pseudoephedrine 12 Hour. Antacids can make it harder for your body to absorb this medication.

Ask a doctor or pharmacist before using any other cold or allergy medicine. Many combination medicines contain pseudoephedrine. Taking certain products together can cause you to get too much of Fexofenadine HCl-Pseudoephedrine 12 Hour.

Drinking alcohol can increase certain side effects of this medication.

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

Fexofenadine HCl-Pseudoephedrine 12 Hour may cause serious side effects. Stop using Fexofenadine HCl-Pseudoephedrine 12 Hour and call your doctor at once if you have:

• pounding heartbeats or fluttering in your chest; or

• severe dizziness, anxiety, restless feeling, tremors, or nervousness.

Common side effects of Fexofenadine HCl-Pseudoephedrine 12 Hour may include:

• mild dizziness;

• dry mouth, nose, or throat;

• nausea; or

• sleep problems (insomnia).

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.

Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking Fexofenadine HCl-Pseudoephedrine 12 Hour with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with fexofenadine and pseudoephedrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.