Children's Tylenol Cold + Cough + Runny Nose

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

Chlorpheniramine is an antihistamine that helps lessen the effects of histamine, a natural chemical in the body. Histamine can cause symptoms like sneezing, itching, watery eyes, and runny nose.

Dextromethorphan is a cough suppressant. It works on the brain to reduce the urge to cough.

Children's Tylenol Cold + Cough + Runny Nose is a combination medicine used to relieve headache, fever, body aches, cough, runny nose, sneezing, itching, and watery eyes due to allergies, the common cold, or the flu.

Children's Tylenol Cold + Cough + Runny Nose will not treat a cough that comes from smoking, asthma, or emphysema.

Children's Tylenol Cold + Cough + Runny Nose may also be used for other reasons not mentioned in this medication guide.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use for longer than recommended. Cough and cold medicine is usually taken only for a short time until your symptoms improve.

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

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Stop taking the medicine and call your doctor if you still have a fever after 3 days, or if you still have pain after 10 days (or 5 days if treating a child). Also call your doctor if your symptoms get worse, or if you have 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 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 (Tylenol), chlorpheniramine, or dextromethorphan.

Ask a doctor or pharmacist before taking this medicine if you have any medical condition, especially:

• asthma or COPD, cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;
• a blockage in your stomach or intestines;
• liver disease, cirrhosis, a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;
• kidney disease;
• an enlarged prostate, problems with urination;
• glaucoma; or
• if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

It is not known if this medicine will harm an unborn baby. Do not use cough and cold medicine without a doctor's advice if you are pregnant.

This medicine may pass into breast milk and may harm a nursing baby. Antihistamines may also slow breast milk production. Do not use cough and cold 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).

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult 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 happen even if you have taken acetaminophen before without any 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.

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

• severe headache, seizure (convulsions);
• fast, pounding, or uneven heartbeats;
• confusion, hallucinations, severe dizziness or drowsiness, slow or shallow breathing;
• tremor, restless muscle movements;
• little or no urination;
• flu symptoms, easy bruising, unusual bleeding, pale skin, weakness, feeling light-headed; or
• nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Side effects such as dry mouth, constipation, and confusion may be more likely in older adults.

Common side effects of Children's Tylenol Cold + Cough + Runny Nose may include:

• headache, sleep problems (insomnia);
• upset stomach, diarrhea or constipation;
• dry eyes, blurred vision, dry mouth or nose;
• mild dizziness or drowsiness, trouble concentrating;
• feeling restless or excited (especially in children); or
• mild skin rash.

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 Children's Tylenol Cold + Cough + Runny Nose is taken as needed, you might not have a specific 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 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 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.

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 result in too much acetaminophen, which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen, and can heighten certain side effects of chlorpheniramine.

This medication may cause blurred vision and may affect your thinking or reactions. Be cautious if you drive or do anything that requires you to be alert and able to see clearly.

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 Children's Tylenol Cold + Cough + Runny Nose with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.