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naproxen and pseudoephedrine (cont.)

What should I discuss with my healthcare provider before taking naproxen and pseudoephedrine (Aleve Cold and Sinus, Aleve Sinus & Headache)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take a cough or cold medicine before the MAO inhibitor has cleared from your body.

Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Do not use this medication if you are allergic to naproxen and pseudoephedrine, or if you have a history of allergic reaction to aspirin or other NSAIDs.

Before taking naproxen and pseudoephedrine, tell your doctor if you are allergic to any drugs, or if you have:

If you have any of these conditions, you may not be able to use naproxen and pseudoephedrine, or you may need a dosage adjustment or special tests during treatment.

This medication may be harmful to an unborn baby. Taking naproxen during the last 3 months of pregnancy may result in birth defects. Do not take naproxen and pseudoephedrine during pregnancy unless your doctor has told you to.

Naproxen and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take naproxen and pseudoephedrine (Aleve Cold and Sinus, Aleve Sinus & Headache)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. The extended-release pill is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Call your doctor if you have a fever lasting longer than 3 days, if you have new symptoms, or if your condition does not improve after taking this medication for 7 days.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store naproxen and pseudoephedrine at room temperature away from moisture and heat.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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