Aleve PM contains a combination of diphenhydramine and naproxen. Diphenhydramine is an antihistamine. Naproxen is a nonsteroidal anti-inflammatory drug (NSAID).

Aleve PM is 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.

Aleve PM is for use in adults and children at least 12 years old.

Use Aleve PM exactly as directed. Taking too much diphenhydramine can lead to serious heart problems, seizures, coma, or death.

Naproxen can increase your risk of fatal heart attack or stroke. Do not use Aleve PM 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.

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

Taking too much diphenhydramine can lead to serious heart problems, seizures, coma, or death.

Aleve PM is not approved for use by anyone younger than 12 years old. Always ask a doctor before giving an antihistamine to a child. Death can occur from the misuse of antihistamines in very young children.

Take Aleve PM with food or milk if it upsets your stomach.

Do not take this medicine if you do not have a full 7 to 8 hours to sleep before being active again. Do not take this medicine for longer than 10 days without your doctor's advice.

Call your doctor if your symptoms do not improve after 10 days, or if they get worse.

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.

Usual Adult Dose for Insomnia:

Initial dose: 2 caplets at bedtime
Maximum dose: 2 caplets in 24 hours

Use: To relief occasional sleeplessness associated with minor aches

Usual Adult Dose for Pain:

Initial dose: 2 caplets at bedtime
Maximum dose: 2 caplets in 24 hours

Use: To relief occasional sleeplessness associated with minor aches

Usual Pediatric Dose for Insomnia:

For children over 12 years old.
Initial dose: 2 caplets at bedtime
Maximum dose: 2 caplets in 24 hours

Usual Pediatric Dose for Pain:

For children over 12 years old.
Initial dose: 2 caplets at bedtime
Maximum dose: 2 caplets in 24 hours

Naproxen can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use Aleve PM 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 Aleve PM, especially in older adults.

You should not use Aleve PM 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 Aleve PM 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 Aleve PM 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.

Since Aleve PM 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 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.

Get emergency medical help if you have signs of an allergic reaction to Aleve PM (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 Aleve PM 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.

Ask your doctor before using Aleve PM 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 Aleve PM with any other medications, especially:

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

• a diuretic or "water pill"; or

• diphenhydramine (Benadryl) used on the skin.

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