Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). Pseudoephedrine is a decongestant.

Sudafed PSE is a combination medicine used to treat stuffy nose, sinus congestion, headache, fever, and minor aches and pains caused by the common cold or flu.

Sudafed PSE may also be used for purposes not listed in this medication guide.

Naproxen can increase your risk of fatal heart attack or stroke. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Naproxen may also cause stomach or intestinal bleeding, which can be fatal.

Use exactly as directed on the label, or as prescribed by your doctor. Use the lowest dose that is effective in treating your condition.

Swallow the tablet whole and do not crush, chew, or break it.

Take this medicine with a full glass of water.

Take with food or milk if this medicine upsets your stomach.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken this medicine within the past few days.

Call your doctor if you have a fever lasting longer than 3 days, or if your symptoms do not improve after 7 days of taking this medicine.

Store at room temperature away from moisture and heat.

Naproxen can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use Sudafed PSE just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using naproxen, especially in older adults.

You should not use this medicine if you are allergic to naproxen or pseudoephedrine, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Do not use Sudafed PSE if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

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

• heart disease, high blood pressure, diabetes;

• a heart attack or stroke;

• a stomach ulcer or bleeding;

• asthma;

• a thyroid disorder;

• enlarged prostate, urination problems;

• liver or kidney disease; or

• if you drink 3 or more alcoholic drinks per day.

Do not use Sudafed PSE during pregnancy unless your doctor tells you to. Using an NSAID in the last 20 weeks can harm the unborn baby or cause pregnancy complications.

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

Not approved for use by anyone younger than 12 years old.

Since cold 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.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin unless your doctor tells you to.

Ask a doctor or pharmacist before using other cough or cold medicines that may contain similar ingredients.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, feeling light-headed, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Sudafed PSE may cause serious side effects. Stop using Sudafed PSE and call your doctor at once if you have:

• severe dizziness or nervousness, trouble sleeping;

• swelling, rapid weight gain;

• shortness of breath;

• new or worsening stomach pain; or

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects of Sudafed PSE may include:

• heartburn, stomach pain, nausea, vomiting;

• dizziness;

• sleep problems (insomnia); or

• feeling nervous or excited.

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 your doctor before using Sudafed PSE if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist before using Sudafed PSE with any other medications, especially:

• a blood thinner (warfarin, Coumadin, Jantoven);

• heart or blood pressure medication, including a diuretic or "water pill"; or

• steroid medicine (such as prednisone).

This list is not complete. Other drugs may affect Sudafed PSE, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.