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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 (eye BYOO proe fen) is a non-steroidal anti-inflammatory drug (NSAID). It can ease minor aches and pains caused by a cold, flu, sore throat, headache, or toothache. It is used to treat fever or pain for a short time.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

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

How should I use this medicine?

Take this medicine by mouth. 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. Shake well before using. Use the dropper provided in the package. Do not use any other dosing device. 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 months old for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If a dose is missed, give it as soon as you can. If it is almost time for the next dose, give only that dose. Do not give 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:

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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.

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.

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.


Last Updated: May 07, 2009
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