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|Bayer Children"s Chewable Tablets

Bayer Children"s Chewable Tablets

Bayer Children"s Chewable Tablets is used for:

Treatment of aches and pains associated with headache, common cold, and sore throat and for reduction of fever. It may be used to reduce the risk of death and lessen the damaging effects of an acute heart attack. It is also used to reduce the risk of heart attacks and strokes in certain men and women who have already had a heart attack or ischemic stroke. It may also be used to treat certain conditions as determined by your doctor which may not be listed in the professional package insert.

Bayer Children"s Chewable Tablets is a nonsteroidal anti-inflammatory drug (NSAID). It works by inhibiting several different chemical processes within the body that cause pain, inflammation, and fever. It also reduces the tendency for blood to clot.

Do NOT use Bayer Children"s Chewable Tablets if:

• you are allergic to any ingredient in Bayer Children"s Chewable Tablets
• you are a child or teenager with influenza (flu) or chickenpox
• you have bleeding problems such as hemophilia, von Willebrand disease, or low blood platelets
• you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness), to aspirin, tartrazine, or an NSAID (eg, ibuprofen, naproxen, celecoxib)
• you are taking anticoagulants (eg, heparin, warfarin) or methotrexate

Contact your doctor or health care provider right away if any of these apply to you.

Before using Bayer Children"s Chewable Tablets:

Some medical conditions may interact with Bayer Children"s Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines or other substances
• if you have alcoholism or if you consume 3 or more alcohol containing drinks every day
• if you have asthma, bleeding or clotting problems, growths in the nose (nasal polyps), kidney or liver problems, stomach or peptic ulcers (bleeding ulcers), heartburn, upset stomach, stomach pain, influenza (flu) or chicken pox, or vitamin K deficiency
• if you are a child with a stroke, a weakened blood vessel (cerebral aneurysm) or bleeding in the brain, or Kawasaki syndrome (a rare inflammation causing heart problems in children)

Some MEDICINES MAY INTERACT with Bayer Children"s Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Carbonic anhydrase inhibitors (eg, acetazolamide) because the effectiveness of Bayer Children"s Chewable Tablets may be decreased
• Anticoagulants (eg, heparin, warfarin) or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, celecoxib) because side effects, including risk of bleeding, may be increased by Bayer Children"s Chewable Tablets
• Insulin and oral antidiabetics (eg, glyburide, nateglinide) because side effects, including abnormally low blood sugar level (eg, hunger, shakiness or weakness, dizziness, headache, sweating), may be increased by Bayer Children"s Chewable Tablets
• Methotrexate or valproic acid because their actions and side effects may be increased by Bayer Children"s Chewable Tablets
• Angiotensin-converting enzyme inhibitors (eg, enalapril), probenecid, or sulfinpyrazone because their effectiveness may be decreased by Bayer Children"s Chewable Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Bayer Children"s Chewable Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Bayer Children"s Chewable Tablets:

Use Bayer Children"s Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Bayer Children"s Chewable Tablets may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Bayer Children"s Chewable Tablets may be swallowed whole, chewed, or crushed and dissolved in a glass of water, milk, or juice before swallowing.
• Take Bayer Children"s Chewable Tablets with a full glass of water.
• Use Bayer Children"s Chewable Tablets exactly as directed on the package, unless instructed differently by your doctor. If you are taking Bayer Children"s Chewable Tablets without a prescription, follow any warnings and precautions on the label.
• If you miss a dose of Bayer Children"s Chewable Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Bayer Children"s Chewable Tablets.

Important safety information:

• Do not take Bayer Children"s Chewable Tablets for more than 10 days for pain or for more than 3 days for fever unless directed to do so by your health care provider.
• Bayer Children"s Chewable Tablets contains aspirin. Before you begin taking any new prescription or over-the-counter medicine, read the ingredients to see if it also contains an aspirin-like medicine. If it does or if you are uncertain, contact your doctor or pharmacist.
• If you consume 3 or more alcohol-containing drinks every day, ask your doctor whether you should take Bayer Children"s Chewable Tablets or other pain relievers/fever reducers. Bayer Children"s Chewable Tablets may cause stomach bleeding. Alcohol use combined with Bayer Children"s Chewable Tablets may increase your risk for stomach bleeding.
• Bayer Children"s Chewable Tablets may reduce the number of blood cells that are needed for clotting. To prevent bleeding, avoid situations where bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark tarry stools to your doctor.
• Bayer Children"s Chewable Tablets contains aspirin, which has been linked to Reye syndrome. Do not give Bayer Children"s Chewable Tablets to children or teenagers during or after chicken pox, flu, or other viral infections without checking with your doctor, nurse, or pharmacist for more information.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Bayer Children"s Chewable Tablets.
• Use Bayer Children"s Chewable Tablets with caution in the ELDERLY because they may be more sensitive to its effects, especially those with a blood coagulation disorder.
• If Bayer Children"s Chewable Tablets has a strong vinegar-like smell upon opening, do not use. It means the medicine is breaking down. Throw the bottle away safely and out of the reach of children; contact your pharmacist and replace.
• Bayer Children"s Chewable Tablets is not recommended for use in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Bayer Children"s Chewable Tablets during pregnancy. Bayer Children"s Chewable Tablets is not recommended during the last 3 months (third trimester) of pregnancy due to the potential for fetal harm or complications during delivery. Bayer Children"s Chewable Tablets is excreted in breast milk. If you are or will be breast-feeding while you are using Bayer Children"s Chewable Tablets, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Bayer Children"s Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Heartburn; nausea; upset stomach.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; confusion; diarrhea; dizziness; drowsiness; hearing loss; ringing in the ears; severe stomach pain; unusual bruising; vomiting.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include agitation; fever; hearing loss; lethargy; lightheadedness, especially upon standing; nausea; rapid breathing; rapid or irregular heartbeat; ringing in the ears; seizures; shortness of breath; stomach pain; vomiting.

Store Bayer Children"s Chewable Tablets at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Bayer Children"s Chewable Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Bayer Children"s Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Bayer Children"s Chewable Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about this medicine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.