Acetaminophen is a pain reliever and fever reducer. Diphenhydramine is an antihistamine. Phenylephrine is a decongestant.

Sudafed PE Severe Cold is a combination medicine used to treat cold and flu symptoms such as runny or stuffy nose, sneezing, cough, sore throat, headache, fever, and body aches.

There are many brands and forms of acetaminophen, diphenhydramine, and phenylephrine available. Not all brands are listed on this leaflet.

Sudafed PE Severe Cold may also be used for purposes not listed in this medication guide.

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.

Use this medicine exactly as directed. An overdose of acetaminophen can damage your liver or cause death. Taking too much diphenhydramine can lead to serious heart problems, seizures, coma, or death.

Do not use this medicine to make a child sleepy. Some brands of Sudafed PE Severe Cold are not approved for use in anyone younger than 12 years old.

Drinking alcohol may increase your risk of liver damage while taking acetaminophen.

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. Cold or cough medicine is only for short-term use until your symptoms clear up.

Do not take more of this medicine than is recommended. An overdose of acetaminophen can damage your liver or cause death. Taking too much diphenhydramine can lead to serious heart problems, seizures, coma, or death.

Some brands of Sudafed PE Severe Cold are not approved for use in anyone younger than 12 years old.

Always follow directions on the medicine label about giving this medicine to a child. Do not use the medicine only to make a child sleepy. Death can occur from the misuse of antihistamines in very young children.

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

Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away.

Call your doctor if you still have a sore throat after 2 days, or if you also have a fever, headache, nausea, vomiting, or rash.

Stop taking this medicine and talk with your doctor if you still have a fever after 3 days, or you still have pain, stuffy nose, or a cough after 7 days (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.

Ask a doctor before taking medicine that contains acetaminophen if you have ever had liver disease, or if you drink more than 3 alcoholic beverages per day.

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 this medicine is safe to use if you have ever had:

• asthma or COPD, cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;

• liver disease;

• high blood pressure, heart disease;

• an enlarged prostate or urination problems;

• a thyroid disorder;

• diabetes;

• glaucoma; or

• a condition for which you take warfarin (Coumadin, Jantoven).

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

Since Sudafed PE Severe Cold 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 can be fatal or cause liver damage.

Overdose symptoms may include loss of appetite, vomiting, weakness, confusion, ringing in your ears, upper stomach pain, dark urine, no urination, very dry eyes and mouth, yellowing of your skin or eyes, dilated pupils, fast heartbeats, tremor, agitation, hallucinations, or seizure.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen or diphenhydramine. This includes medicines for pain, fever, swelling, cold/flu symptoms, or anti-itch medicine used on the skin. Using too much acetaminophen or diphenhydramine can lead to a fatal overdose.

Drinking alcohol may increase your risk of liver damage while taking this medicine.

Get emergency medical help if you have 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.

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

• severe drowsiness;

• painful or difficult urination;

• dizziness, trouble sleeping, nervousness; 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 Sudafed PE Severe Cold may include:

• drowsiness;

• dry eyes, blurred vision;

• dry mouth, nose, or throat;

• constipation; or

• feeling restless or excited (especially in children).

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.

Ask a doctor or pharmacist before using Sudafed PE Severe Cold with any other medicines, especially drugs that can cause drowsiness (such as opioid medication, sleep medicine, a muscle relaxer, or medicine for anxiety or seizures). Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.