Tylenol Cold and Flu Severe

Acetaminophen is a medicine that helps relieve pain and reduce fever.

Dextromethorphan is a medicine that helps stop coughing. It works on the brain to stop the cough reflex.

Guaifenesin is a medicine that helps clear congestion in your chest and throat, making it easier to cough it up.

Phenylephrine is a medicine that acts as a decongestant. It narrows blood vessels in the nasal passages. When blood vessels are widened, it can lead to nasal congestion (a stuffy nose).

Tylenol Cold and Flu Severe is a combination medicine used to treat headache, fever, body aches, cough, chest congestion, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

Tylenol Cold and Flu Severe will not treat a cough caused by smoking, asthma, or emphysema.

Tylenol Cold and Flu Severe may also be used for other reasons 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. This medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than recommended. An acetaminophen overdose can damage your liver or cause death.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

Measure liquid medicine with a special dose measuring spoon or medicine cup, not with a regular tablespoon. If you do not have a dose measuring device, ask your pharmacist for one.

Dissolve one packet of the powder in at least 8 ounces of hot water. Stir and sip drink immediately while the liquid is hot.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

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.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

In rare cases, acetaminophen may cause a severe skin 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.

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 furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

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

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;
• cough with mucus, or cough caused by emphysema or chronic bronchitis;
• pheochromocytoma (an adrenal gland tumor); or
• overactive thyroid.

It is not known whether Tylenol Cold and Flu Severe will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

Acetaminophen, dextromethorphan, guaifenesin, and phenylephrine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Artificially sweetened liquid medicine may contain phenylalanine. Check the medication label if you have phenylketonuria (PKU).

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

In rare instances, acetaminophen can cause a severe skin reaction that might be deadly. This can happen even if you have previously taken acetaminophen without any issues. Stop taking this medicine and contact your doctor immediately if you notice skin redness or a rash that spreads and causes blistering and peeling. If you experience this kind of reaction, you should never take any medicine that contains acetaminophen again.

This medicine may cause serious side effects. Stop using it and call your doctor right away if you have:

• chest pain, fast, slow, or uneven heart rate;
• severe dizziness, feeling like you might faint;
• mood changes, confusion, hallucinations;
• tremors, seizures (convulsions);
• fever;
• urinating less than usual or not at all;
• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or
• dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, anxiety, chest pain, uneven heartbeats, seizures).

Common side effects of Tylenol Cold and Flu Severe 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; others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Since Tylenol Cold and Flu Severe is taken as needed, you might not follow a dosing schedule. If you are on a schedule, 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 use extra medicine to compensate for the missed dose.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. Taking too much acetaminophen can be deadly.

The early signs of an acetaminophen overdose include not wanting to eat, feeling nauseous, vomiting, stomach pain, sweating, and feeling confused or weak. Later signs may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Do not drink alcohol. It can increase your risk of liver damage while you are using acetaminophen.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medicine. Acetaminophen (sometimes written as APAP) is found in many combination medicines. Taking certain products together can lead to getting too much acetaminophen, which can cause a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

This medication may affect your thinking or reactions. Be cautious if you drive or do anything that needs you to be alert.

Ask a doctor or pharmacist before using this medicine if you are taking any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are listed in this medication guide.

Taking this medicine with other drugs that make you sleepy or slow your breathing can make these effects worse. Ask your doctor before taking acetaminophen, dextromethorphan, and phenylephrine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.