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

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

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

Ibuprofen 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).

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

You should not use this medicine if you are allergic to diphenhydramine or ibuprofen, 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. Taking ibuprofen during the last 20 weeks of pregnancy may result in serious kidney problems in the unborn baby.

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

Use Ibuprofen PM (Oral) 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;
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• kidney problems--little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or
• liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• drowsiness;
• day-time drowsiness, dizziness, "hangover" feeling;
• upset stomach, heartburn, diarrhea, constipation;
• dry mouth, nose, or throat;
• blurred vision;
• mild itching or rash; or
• ringing in your ears.

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 ibuprofen. Also avoid using diphenhydramine anti-itch medicine on your skin.

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

Avoid taking aspirin unless your doctor tells you to.