Diphenhydramine is an antihistamine. Naproxen is a nonsteroidal anti-inflammatory drug (NSAID).

Diphenhydramine and naproxen is a combination medicine used to treat occasional insomnia associated with minor aches and pains. This medicine is not for use in treating sleeplessness without pain, or sleep problems that occur often.

Diphenhydramine and naproxen is for use in adults and children at least 12 years old.

Diphenhydramine and naproxen may also be used for purposes not listed in this medication guide.

Naproxen can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. 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. These conditions can occur without warning while you are using diphenhydramine and naproxen, especially in older adults.

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

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

• heart disease, high blood pressure;
• a heart attack, stroke, or blood clot;
• stomach ulcers or bleeding;
• a breathing problem, such as asthma, emphysema, or bronchitis;
• liver or kidney disease;
• glaucoma;
• enlarged prostate or problems with urination; or
• if you take aspirin to prevent heart attack or stroke.

Ask a doctor before using this medicine if you are pregnant or plan to become pregnant.

If you are pregnant, you should not take this medicine unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

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

Use Diphenhydramine And Naproxen (Aleve Pm) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with 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.

Stop using this medicine and call your doctor at once if you have:

• any skin rash, no matter how mild;
• a light-headed feeling, like you might pass out;
• new symptoms, such redness or swelling with pain; or
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects may include:

• drowsiness;
• day-time drowsiness, dizziness, "hangover" feeling;
• upset stomach, heartburn;
• constipation;
• blurred vision; or
• dry mouth, nose, or throat.

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.

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 other medicines for pain, fever, swelling, or cold/flu symptoms. They may also contain diphenhydramine or naproxen. Also avoid using diphenhydramine anti-itch medicine on your skin.

Avoid taking aspirin unless your doctor tells you to.

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