This combination medication is used to temporarily treat runny/stuffy nose and other symptoms (e.g., ear congestion, watery/itchy eyes, itchy throat) caused by allergies, hay fever, the common cold, or other breathing illnesses (e.g., sinusitis). Decongestants help to relieve stuffy nose and ear congestion symptoms. Antihistamines relieve watery eyes, itchy eyes/nose/throat, runny nose, and sneezing.

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.

These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

If you are taking the over-the-counter product, 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 with or without food with a full glass of water (8 ounces or 240 milliliters) or as directed by your doctor. This medication may be taken with food or milk if stomach upset occurs.

If you are using the liquid form, use a medication measuring device to carefully measure the prescribed dose. Do not use a household spoon because you may not get the correct dose. If your liquid form is a suspension, shake the bottle well before each dose.

If you are using sustained-release tablets or capsules, swallow the medication whole. Do not crush, chew, or break the tablets or capsules. Doing so can destroy the long action of the drug and may increase side effects.

If you are using chewable tablets, chew each tablet thoroughly before swallowing.

If you are using a product made to dissolve in the mouth (tablets/strips), dry your hands before handling the medication. Place each dose on the tongue and allow to dissolve completely, then swallow it with saliva or with water.

Dosage is based on the product you are taking and your age, medical condition, and response to treatment. Do not increase your dose or take this medication more often than directed without your doctor's approval. Improper use (abuse) of this medication may result in serious harm (e.g., hallucinations, seizure, death).

If your doctor directs you to take this medication daily, take it regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

If your symptoms worsen or do not improve after 7 days, if you also have fever/chills, or if you think you may have a serious medical problem, seek immediate medical attention.

Drowsiness, dizziness, dry mouth/nose/throat/eyes, blurred vision, fast heartbeat, trouble sleeping, restlessness, irritability, headache, upset stomach, shaking, or constipation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

This product may reduce blood flow to your hands and feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use.

If your doctor has prescribed this medication, remember that he or she 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 immediately if any of these unlikely but serious side effects occur: fast/irregular heartbeat, mental/mood changes (e.g., confusion, hallucinations), ringing in the ears, difficulty urinating, weakness.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, seizure.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.

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 product, tell your doctor or pharmacist if you are allergic to any of its ingredients; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood vessel problems (e.g., low blood flow to the brain/legs/hands), breathing problems (e.g., asthma, emphysema), diabetes, glaucoma, heart disease (e.g., angina, fast/irregular heartbeat, heart failure), high blood pressure, kidney problems, liver disease, seizure disorder, stomach/intestinal problems (e.g., ulcers, blockage), overactive thyroid (hyperthyroidism), trouble urinating (e.g., due to enlarged prostate, urinary retention).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Liquid products, chewable tablets, or dissolving tablets/strips may contain sugar or aspartame. Liquid products may also contain alcohol. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially dizziness, drowsiness, urination problems, and vision problems.

Caution is advised when using this drug in children because they may be more sensitive to its side effects, especially excitation and agitation.

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

This medication may pass into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

If you are taking this product under your doctor's direction, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because very serious interactions may occur: MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine).

Avoid taking MAO inhibitors within 2 weeks before, during, and after treatment with this medication. In some cases a serious, possibly fatal drug interaction may occur.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other antihistamines, blood pressure medications (especially reserpine, guanethidine, methyldopa, beta blockers such as atenolol, or calcium channel blockers such as nifedipine), other decongestants (taken by mouth or applied in the nose), digoxin, tricyclic antidepressants (e.g., amitriptyline, desipramine).

The decongestant in this product may worsen the serious side effects of some medications for migraine headaches (e.g., sumatriptan, naratriptan, zolmitriptan, ergotamine). If you are taking any of these migraine medications, tell your doctor before starting this decongestant product.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).

Check the labels on all your medicines (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could affect your heart rate/blood pressure or cause drowsiness. Ask your pharmacist about the safe use of those products.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: irregular heartbeat, hallucinations, hot/dry skin, fainting, seizures.

If your doctor has prescribed this medication, do not share it with others.

Keep all regular medical and laboratory appointments.

Do not take this product for several days before allergy testing because test results can be affected.

If you are taking this product on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store at room temperature at 59-86 degrees F (15-30 degrees C) or as directed on the package label, away from light and moisture. Do not store in the bathroom. Do not freeze liquid forms of this medication. Keep all medicines 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 for more details about how to safely discard your product.

Information last revised July 2009 Copyright(c) 2009 First DataBank, Inc.