Non-Drowsy Daytime

You should not use this medication if you are allergic to acetaminophen, dextromethorphan, or pseudoephedrine.

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:

• liver disease, alcoholism, or if you drink more than 3 alcoholic beverages per day;

• high blood pressure, heart disease, coronary artery disease, or recent heart attack;

• diabetes;

• glaucoma;

• epilepsy or other seizure disorder;

• enlarged prostate or urination problems;

• pheochromocytoma (an adrenal gland tumor); or

• cough with mucus, or cough caused by emphysema or chronic bronchitis.

It is not known whether acetaminophen, dextromethorphan, and pseudoephedrine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

This medication may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use this medicine without your doctor's advice if you are breast-feeding a baby.

Artificially sweetened cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

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

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using this medicine and call your doctor at once if you have:

• chest pain, rapid pulse, fast or uneven heart rate;

• severe dizziness, feeling like you might pass out;

• mood changes, confusion, hallucinations;

• tremor, seizure (convulsions);

• fever;

• little or no urinating;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes; or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

Common side effects may include:

• dizziness, weakness;

• mild headache;

• mild nausea, diarrhea, upset stomach;

• dry mouth, nose, or throat;

• feeling nervous, restless, irritable, or anxious; 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.

Other drugs may interact with acetaminophen, dextromethorphan, 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.