Delsym Cough and Sore Throat is a combination medicine used to treat cough, sore throat, headache, fever, and minor aches and pain or fever caused by throat irritation or the common cold.

Delsym Cough and Sore Throat will not treat a cough that is caused by smoking, asthma, or emphysema.

Delsym Cough and Sore Throat may also be used for purposes not listed in this medication guide.

You should not use Delsym Cough and Sore Throat if you have severe liver disease.

Use this medicine exactly as directed. 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).

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.

Use exactly as directed on the label, or as prescribed by your doctor. An acetaminophen overdose can damage your liver or cause death. Cold or cough medicine is only for short-term use until your symptoms clear up.

If you are treating a child, use a pediatric form of acetaminophen and dextromethorphan. Use only the special dose-measuring dropper or oral syringe that comes with the specific pediatric form you are using. Carefully follow the dosing directions on the medicine label.

You must chew the chewable tablet before you swallow it.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Call your doctor if you have a fever for longer than 3 days, or if your pain or cough gets worse or lasts more than 5 days.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken Delsym Cough and Sore Throat within the past few days.

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

You should not take acetaminophen if you are allergic to it, or if you have:

• severe liver disease; or

• if you have taken an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Ask a doctor or pharmacist if this medicine is safe to use if you have:

• a chronic cough, or a cough with mucus; or

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

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

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

Since this medicine is used when needed, you may not be on a dosing schedule. Skip any missed dose if it's almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can damage your liver or cause death.

Early signs of acetaminophen overdose include loss of appetite, nausea, vomiting, sweating, or weakness. Later symptoms may include upper stomach pain, dark urine, and yellowing of your skin or eyes.

Avoid drinking alcohol. It may increase your risk of liver damage.

Ask a doctor or pharmacist before using any other medicine that may contain dextromethorphan or acetaminophen (sometimes abbreviated as APAP). Taking too much acetaminophen can lead to a fatal overdose.

Avoid driving or hazardous activity until you know how Delsym Cough and Sore Throat will affect you. Your reactions could be impaired.

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 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.

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

• redness or swelling;

• new or worsening symptoms;

• an ongoing cough with a rash or headache; or

• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of Delsym Cough and Sore Throat may include:

• upset stomach;

• confusion; or

• drowsiness.

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 affect Delsym Cough and Sore Throat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.