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Drug Notebook

FDA Alerts

Special Alerts:

[Posted 01/17/2008] FDA informed consumers and healthcare professionals that the Agency has completed its review of information regarding the safety of over-the-counter (OTC) cough and cold medicines in children under 2 years of age and recommends that these drugs not be used to treat children in this age group because serious and potentially life-threatening side effects can occur. FDA's recommendation is based on both the review of the information the Agency received about serious side effects in children in the referenced age group and the discussion and recommendations made at the October 18 -19, 2007, public advisory committee meeting at which this issue was discussed. FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age. See the FDA Public Health Advisory for Agency recommendations regarding this issue. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#cough and http://www.fda.gov/cder/drug/advisory/cough_cold_2008.htm.

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ibuprofen
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(eye BYOO proe fen)

What is this medicine?

IBUPROFEN is a non-steroidal anti-inflammatory drug (NSAID). The medicine may be used for dental pain, fever, headaches or migraines, osteoarthritis, rheumatoid arthritis, or painful monthly periods. It can also relieve minor aches and pains caused by a cold, flu, or sore throat.

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

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

  • asthma
  • cigarette smoker
  • drink more than 3 alcohol containing drinks a day
  • heart disease or circulation problems such as heart failure or leg edema (fluid retention)
  • high blood pressure
  • kidney disease
  • liver disease
  • stomach bleeding or ulcers
  • an unusual or allergic reaction to ibuprofen, aspirin, other NSAIDS, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine with food if your stomach gets upset. Try to not lie down for at least 10 minutes after you take the medicine. Take your medicine at regular intervals. Do not take your medicine more often than directed. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

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.

What may interact with this medicine?

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

This medicine may also interact with the following medications:

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. This medicine does not prevent heart attack or stroke. In fact, this medicine may increase the chance of a heart attack or stroke. The chance may increase with longer use of this medicine and in people who have heart disease. If you take aspirin to prevent heart attack or stroke, talk with your doctor or health care professional. Do not take medicines such as ibuprofen and naproxen with this medicine. Side effects such as stomach upset, nausea, or ulcers may be more likely to occur. Many medicines available without a prescription should not be taken with this medicine. This medicine can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding can happen without warning symptoms and can cause death. To reduce your risk, do not smoke cigarettes or drink alcohol while you are taking this medicine. You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. This medicine can cause you to bleed more easily. Try to avoid damage to your teeth and gums when you brush or floss your teeth.

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