Advil PM Liqui-Gels

Ibuprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

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 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 it is safe for you to use this medicine if you have other medical conditions, especially:

• heart disease, high blood pressure;

• a history of heart attack, stroke, or blood clot;

• a history of 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 drink 3 or more alcoholic beverages per day.

This medicine may be harmful to an unborn baby. Taking ibuprofen during the last 3 months of pregnancy may result in birth defects and prolonged labor and delivery. Do not use this medicine without a doctor's advice if you are pregnant.

Diphenhydramine and ibuprofen may pass into breast milk and may harm a nursing baby. Antihistamines may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

This medicine 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.

Use exactly as directed on the label, or as prescribed by your doctor. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition. This medicine is usually taken only for a short time until your symptoms clear up.

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

Do not take this medicine for longer than 10 days without your doctor's advice.

Call your doctor if your symptoms do not improve, 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.

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Get emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

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:

• the first sign of 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;

• 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);

• kidney problems--little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• drowsiness;

• day-time drowsiness, dizziness, "hangover" feeling;

• upset stomach, mild 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.

Diphenhydramine hydrochloride 25 mg

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug

D&C red no. 33, FD&C blue no. 1, fractionated coconut oil, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol

Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

Advil PM

LIQUI-GELS

Solubilized Ibuprofen, 200 mg / Diphenhydramine HCl, 25 mg

Pain Reliever (NSAID) / Nighttime Sleep-Aid

32 Liqui-Gels*

*Liquid Filled Capsules

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Product inside sealed in plastic blister with foil backing. Do Not Use if plastic blister or foil barrier is broken.

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Distributed by: Wyeth Consumer Healthcare, Madison, NJ 07940 USA ©2009 Wyeth

U.S. Patent Pending

LIQUI-GELS is a trademark or registered trademark of Catalent Pharma Solutions.