Fexofenadine and pseudoephedrine

Fexofenadine is an antihistamine that helps reduce the effects of histamine, a natural chemical in the body. Histamine can cause symptoms like sneezing, itching, watery eyes, and a runny nose.

Pseudoephedrine is a decongestant that helps shrink blood vessels in the nasal passages. When blood vessels are dilated, it can lead to nasal congestion (a stuffy nose).

Fexofenadine and pseudoephedrine is a combination medicine used to treat sneezing, a 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 other purposes that are not listed in this medication guide.

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.

Do not use fexofenadine and pseudoephedrine if you have taken an MAO inhibitor in the last 14 days. This includes medications like isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Do not use fexofenadine and pseudoephedrine if you have taken an MAO inhibitor in the past 14 days. A serious drug interaction could happen. 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.

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

Fexofenadine and pseudoephedrine can cause serious side effects. Stop using fexofenadine and pseudoephedrine and call your doctor immediately if you experience:

• pounding heartbeats or fluttering in your chest; or
• severe dizziness, anxiety, restlessness, tremors, or nervousness.

Common side effects of fexofenadine and pseudoephedrine may include:

• mild dizziness;
• dry mouth, nose, or throat;
• nausea; or
• trouble sleeping (insomnia).

This is not a full list of side effects, and others may happen. Contact your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Allergic Rhinitis:

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

Since cold or allergy medicine is taken as needed, you might not have a specific dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose. Do not take extra medicine to compensate for the missed dose.

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

Do not use 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.

Taking this medicine with other drugs that make you sleepy or slow your breathing can make these effects worse. 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. Inform each of your health care providers about all medicines you are currently using and any medicine you begin or stop using.