Mucinex Children's Cold, Cough and Sore Throat

Acetaminophen is a medicine that relieves pain and reduces fever.

Dextromethorphan is a medicine that suppresses coughs. It works on the brain signals that cause the cough reflex.

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

Phenylephrine is a medicine that reduces nasal congestion by shrinking the blood vessels in the nasal passages. When blood vessels are enlarged, it can lead to a stuffy nose.

Mucinex Children's Cold, Cough and Sore Throat 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.

Mucinex Children's Cold, Cough and Sore Throat will not treat a cough that is caused by smoking, asthma, or emphysema.

Mucinex Children's Cold, Cough and Sore Throat may also be used for other purposes 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 table spoon. 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 the 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 last 14 days. A dangerous drug interaction could happen. 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 Mucinex Children's Cold, Cough and Sore Throat 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 down 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 have signs of an allergic reaction: hives; trouble breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This can happen even if you have taken acetaminophen before 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 take any medicine that contains acetaminophen again.

This medicine may cause serious side effects. Stop using this medicine and call your doctor immediately if you have:

• chest pain, fast, slow, or uneven heart rate;
• severe dizziness, feeling like you might faint;
• mood changes, confusion, hallucinations;
• tremor, seizure (convulsions);
• fever;
• urinating less than usual or not at all;
• nausea, pain in your upper stomach, 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, seizure).

Common side effects of Mucinex Children's Cold, Cough and Sore Throat 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.

Since Mucinex Children's Cold, Cough and Sore Throat is taken as needed, you may not have a regular dosing schedule. If you do have a schedule and miss a dose, take it as soon as you remember. If it's almost time for your next scheduled dose, skip the missed dose. Do not take extra medicine to make up 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 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.

Avoid drinking alcohol. It may raise your risk of liver damage while you are taking acetaminophen.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes called APAP) is found in many combination medicines. Taking certain products together can lead to taking too much acetaminophen, which can result in 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 stay alert.

Ask a doctor or pharmacist before using this medicine if you are also 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 included 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.