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 and pseudoephedrine 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 and pseudoephedrine may also be used for purposes not listed in this medication guide.

Do not use fexofenadine and pseudoephedrine 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 and pseudoephedrine on an empty stomach, at least 1 hour before or 2 hours after a meal.

Take fexofenadine and pseudoephedrine 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.

Usual Adult Dose for Allergic Rhinitis:

1 tablet (60 mg-120 mg) orally every 12 hours
Maximum dose: 2 tablets per 24 hours

Usual Pediatric Dose for Allergic Rhinitis:

12 years and older: 1 tablet (60 mg-120 mg) orally every 12 hours
Maximum dose: 2 tablets per 24 hours

Do not use fexofenadine and pseudoephedrine 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 and pseudoephedrine 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Caffeine-containing beverages (coffee, tea, sodas, and energy drinks) may increase the restlessness and insomnia caused by pseudoephedrine in sensitive individuals, so you may wish to drink less of these beverages. Talk to your doctor about drinking these beverages while taking this medication.

Avoid using antacids within 15 minutes before or after taking fexofenadine and pseudoephedrine. 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 and pseudoephedrine.

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 and pseudoephedrine may cause serious side effects. Stop using fexofenadine and pseudoephedrine 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 and pseudoephedrine 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 and pseudoephedrine 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.

If you are taking fexofenadine and pseudoephedrine 12-hour tablets, you may notice something that looks like a tablet in your stool. This is just the empty tablet shell, and this does not mean that you did not get your complete dose of medication.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.