Sudafed PE Severe Cold

Acetaminophen is a medicine that helps relieve pain and reduce fever. Diphenhydramine is a type of antihistamine. Phenylephrine is a decongestant.

Sudafed PE Severe Cold is a combination medicine used to treat symptoms of cold and flu, including 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 mentioned in this leaflet.

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

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 improve.

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

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

Always follow the directions on the medicine label when giving this medicine to a child. Do not use the medicine just to make a child sleepy. Antihistamines can cause death if misused in very young children.

Measure liquid medicine carefully. Use the dosing syringe provided, or 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 immediately.

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 if 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 worsen, or if you notice any redness or swelling.

If you need surgery or medical tests, inform the surgeon or doctor in advance if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat.

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.

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.

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

In rare cases, acetaminophen can cause a severe skin reaction that may be life-threatening. This can happen even if you have taken acetaminophen before without any issues. Stop using this medicine and contact your doctor immediately if you experience skin redness or a rash that spreads and leads to blistering and peeling. If you have this type of reaction, you should never take any medicine that contains acetaminophen again.

This medicine may lead to serious side effects. Stop taking this medicine and call your doctor right away if you experience:

• 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 can 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. Contact your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Since Sudafed PE Severe Cold is taken as needed, you might not have a regular dosing schedule. If you miss a dose and it’s close to the time for your next dose, just skip the missed dose. Do not take two doses at the same time.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. Taking too much of this medicine can be deadly or cause liver damage.

Signs of an overdose may include not wanting to eat, throwing up, feeling weak, being confused, ringing in your ears, pain in your upper stomach, dark urine, not being able to urinate, very dry eyes and mouth, yellowing of your skin or eyes, dilated pupils, rapid heartbeats, shaking, feeling restless, seeing things that aren't there, or having a seizure.

Do not drive or do anything dangerous until you know how this medicine affects you. Your reactions may be slower.

Talk to a doctor or pharmacist before using any other medicine that may have acetaminophen or diphenhydramine in it. This includes medicines for pain, fever, swelling, cold/flu symptoms, or skin anti-itch medicine. Taking too much acetaminophen or diphenhydramine can cause a fatal overdose.

Drinking alcohol may raise your chances of liver damage while using this medicine.

Ask a doctor or pharmacist before using Sudafed PE Severe Cold with any other medicines, especially those that can make you drowsy (like opioid medication, sleep medicine, a muscle relaxer, or medicine for anxiety or seizures). Let your doctor know about all the medicines you are currently taking and any medicine you begin or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.