Ibuprofen Chewable Oral Tablets

What is this medicine?

IBUPROFEN (eye BYOO proe fen) is a non-steroidal anti-inflammatory drug, also known as an NSAID. It treats pain, inflammation, and swelling. It also reduces fever and minor aches and pains caused by the cold, flu, or a sore throat.

How should I use this medicine?

Take this medicine by mouth. Chew it completely before swallowing. Follow the directions on the package label. Read the directions on the package label very carefully. Use the child's weight or age to find the correct dose. Give with food or a drink to prevent throat burning. If this medicine upsets the stomach, give with food or milk. Do NOT give more than directed. Doses should not be given more than 4 times in one day.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 6 years old for selected conditions, precautions do apply.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)

• aseptic meningitis (stiff neck; sensitivity to light; headache; drowsiness; fever; nausea, vomiting; rash)

• bleeding (bloody or black, tarry stools; red or dark brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eyes, gums, or nose)

• blurred vision OR changes in vision

• heart attack (trouble breathing; pain or tightness in the chest, neck, back or arms; unusually weak or tired)

• heart failure (trouble breathing; fast, irregular heartbeat; sudden weight gain; swelling of the ankles, feet, hands; unusually weak or tired)

• high potassium levels (chest pain; fast, irregular heartbeat; muscle weakness)

• increase in blood pressure

• infection (fever, chills, cough, sore throat, pain or trouble passing urine)

• kidney injury (trouble passing urine or change in the amount of urine)

• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired, yellowing of the eyes or skin)

• low blood pressure (dizziness; feeling faint or lightheaded, falls; unusually weak or tired)

• low red blood cell counts (trouble breathing; feeling faint; lightheaded, falls; unusually weak or tired)

• redness, blistering, peeling, or loosening of the skin, including inside the mouth

• stroke (changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination)

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea

• dizziness

• feeling faint or lightheaded, falls

• headache

• stomach pain

• vomiting

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• cidofovir

• ketorolac

• methotrexate

• pemetrexed

This medicine may also interact with the following medications:

• alcohol

• aspirin

• diuretics

• lithium

• other drugs for inflammation like prednisone

• warfarin

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children and pets.

Store at room temperature between 20 to 25 degrees C (68 to 77 degrees F). Throw away any unused drug after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bleeding disorder

• coronary artery bypass graft (CABG) within the past 2 weeks

• heart attack

• heart disease

• heart failure

• high blood pressure

• kidney disease

• liver disease

• lung or breathing disease (asthma)

• phenylketonuria (PKU)

• receiving steroids like dexamethasone or prednisone

• stomach bleeding

• stomach ulcers, other stomach or intestine problems

• take drugs that treat or prevent blood clots

• an unusual or allergic reaction to ibuprofen, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

A painful sore throat or sore throat with high fevers, headaches, nausea, or vomiting may be signs of a serious infection. Call your health care provider if these symptoms occur. Do not use this drug for more than 2 days or give to children under 3 years of age unless your health care provider tells you to.

Do not take other drugs that contain aspirin, ibuprofen, or naproxen with this drug. Side effects such as stomach upset, nausea, or ulcers may be more likely to occur. Many non-prescription drugs contain aspirin, ibuprofen, or naproxen. Always read labels carefully.

This drug can cause serious ulcers and bleeding in the stomach. It can happen with no warning. Smoking, drinking alcohol, older age, and poor health can also increase risks. Call your health care provider right away if you have stomach pain or blood in your vomit or stool.

This drug may cause serious skin reactions. They can happen weeks to months after starting the drug. Contact your health care provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

This product may contain aspartame, which is a source of phenylalanine. If you have phenylketonuria (PKU), contact your health care provider for advice.

This drug does not prevent a heart attack or stroke. This drug may increase the chance of a heart attack or stroke. The chance may increase the longer you use this drug or if you have heart disease. If you take aspirin to prevent a heart attack or stroke, talk to your health care provider about using this drug.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.