This combination medication is used to temporarily relieve symptoms caused by the common cold, flu, or allergies. It contains 2 medications: fexofenadine and pseudoephedrine. Fexofenadine is an antihistamine that helps relieve watery eyes, itchy eyes/nose/throat, runny nose, and sneezing. Pseudoephedrine is a decongestant that helps relieve stuffy nose and ear congestion symptoms.

This medication is not recommended for use in children under 12 years of age due to the large amount of pseudoephedrine in it.

If you are taking the over-the-counter product to self-treat, read all directions on the product package before taking this medication. If you have any questions, consult your pharmacist. If your doctor has prescribed this medication, take it as directed.

Take this medication by mouth on an empty stomach (at least 1 hour before or 2 hours after a meal). Take this medication with water. Do not take with fruit juices (such as apple, grapefruit, or orange) since they may decrease the absorption of this drug.

Swallow the tablets whole. Do not crush or chew the tablets. Doing so can release all of the drug at once, increasing the risk of side effects.

The dosage is based on your medical condition and response to treatment. Do not increase your dose or take this medication more often than directed.

Do not take antacids containing aluminum and magnesium within 2 hours of taking this medication. These antacids can decrease the absorption of fexofenadine.

Tell your doctor if your symptoms do not get better after 1 week, if they get wose, or if they occur with a fever.

Dizziness, trouble sleeping, nausea, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

An empty tablet shell may appear in your stool. This effect is harmless because your body has already absorbed the medication.

If your doctor has prescribed this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• fast/irregular/pounding heartbeat
• shaking (tremor)
• mental/mood changes (such as anxiety, confusion, nervousness, restlessness)
• problems urinating

Get medical help right away if you have any very serious side effects, including:

• seizures

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this medication, tell your doctor or pharmacist if you are allergic to fexofenadine or pseudoephedrine; or if you have any other allergies. Also, tell your doctor if you have had serious side effects from similar medications (such as other decongestants, including phenylephrine). This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• glaucoma
• difficulty urinating (such as due to an enlarged prostate)
• high blood pressure (hypertension)
• heart/blood vessel disease (such as coronary artery disease)
• overactive thyroid (hyperthyroidism)
• diabetes
• kidney disease

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially fast/irregular heartbeat, dizziness, problems urinating, trouble sleeping, or confusion.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

Check the labels on all your medicines (such as cough-and-cold products) because they may contain similar ingredients (decongestants such as phenylephrine). Ask your pharmacist about using those products safely.

This medication may interfere with certain lab tests (such as allergy skin testing), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: fast/irregular heartbeat, mental/mood changes (such as anxiety, restlessness), seizures.

Keep all medical and lab appointments.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Different brands of this medication may have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.