Smart Sense Children's Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID).

Smart Sense Children's Ibuprofen is used to reduce fever and treat pain or inflammation caused by many conditions such as headache, toothache, back pain, arthritis, menstrual cramps, or minor injury. Smart Sense Children's Smart Sense Children's Ibuprofen is used in adults and children who are at least 6 months old.

Smart Sense Children's Ibuprofen may also be used for purposes not listed in this medication guide.

Smart Sense Children's Ibuprofen can increase your risk of fatal heart attack or stroke. Do not use Smart Sense Children's Smart Sense Children's Ibuprofen just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Smart Sense Children's Ibuprofen 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.

An Smart Sense Children's Ibuprofen overdose can damage your stomach or intestines. The maximum amount of Smart Sense Children's Ibuprofen for adults is 800 milligrams per dose or 3200 mg per day (4 maximum doses).

A child's dose of Smart Sense Children's Ibuprofen is based on the age and weight of the child. Carefully follow the dosing instructions provided with children's Smart Sense Children's Ibuprofen for the age and weight of your child. Ask a doctor or pharmacist if you have questions.

Take Smart Sense Children's Ibuprofen with food or milk to lessen stomach upset.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

You must chew the chewable tablet before you swallow it.

Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.

Smart Sense Children's 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).

Smart Sense Children's Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using Smart Sense Children's Ibuprofen, especially in older adults.

You should not use Smart Sense Children's Ibuprofen if you are allergic to it, 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, high cholesterol, diabetes, or if you smoke;

• a heart attack, stroke, or blood clot;

• stomach ulcers or bleeding;

• liver or kidney disease;

• asthma; or

• if you take aspirin to prevent heart attack or stroke.

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

If you are pregnant, you should not take Smart Sense Children's Ibuprofen 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.

Do not give Smart Sense Children's Ibuprofen to a child younger than 6 months old without the advice of a doctor.

Since Smart Sense Children's Smart Sense Children's Ibuprofen 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. Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to Smart Sense Children's Ibuprofen (such as aspirin, Smart Sense Children's Ibuprofen, ketoprofen, or naproxen).

Avoid taking aspirin unless your doctor tells you to.

If you also take aspirin to prevent stroke or heart attack, taking Smart Sense Children's Ibuprofen can make aspirin less effective in protecting your heart and blood vessels. If you take both medicines, take Smart Sense Children's Ibuprofen at least 8 hours before or 30 minutes after you take aspirin (non-enteric coated form).

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

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 Smart Sense Children's Ibuprofen and call your doctor at once if you have:

• changes in your vision;

• shortness of breath (even with mild exertion);

• swelling or rapid weight gain;

• a skin rash, no matter how mild;

• 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);

• low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

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

Common side effects of Smart Sense Children's Ibuprofen may include:

• nausea, vomiting, gas;

• bleeding; or

• dizziness, headache.

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 Smart Sense Children's Ibuprofen 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 Smart Sense Children's Ibuprofen with any other medications, especially:

• cyclosporine;

• lithium;

• methotrexate;

• 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 Smart Sense Children's Ibuprofen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.