Medications and Drugs

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Brand Names: Aleve Cold and Sinus, Aleve Sinus & Headache

Generic Name: naproxen and pseudoephedrine (Pronunciation: na PROX en and soo doe e FED rin)

• What is naproxen and pseudoephedrine (Aleve Cold and Sinus, Aleve Sinus & Headache)?
• What are the possible side effects of naproxen and pseudoephedrine (Aleve Cold and Sinus, Aleve Sinus & Headache)?
• What is the most important information I should know about naproxen and pseudoephedrine (Aleve Cold and Sinus, Aleve Sinus & Headache)?
• What should I discuss with my healthcare provider before taking naproxen and pseudoephedrine (Aleve Cold and Sinus, Aleve Sinus & Headache)?
• How should I take naproxen and pseudoephedrine (Aleve Cold and Sinus, Aleve Sinus & Headache)?
• What happens if I miss a dose (Aleve Cold and Sinus, Aleve Sinus & Headache)?
• What happens if I overdose (Aleve Cold and Sinus, Aleve Sinus & Headache)?
• What should I avoid while taking naproxen and pseudoephedrine (Aleve Cold and Sinus, Aleve Sinus & Headache)?
• What other drugs will affect naproxen and pseudoephedrine (Aleve Cold and Sinus, Aleve Sinus & Headache)?
• Where can I get more information?

What is naproxen and pseudoephedrine (Aleve Cold and Sinus, Aleve Sinus & Headache)?

Naproxen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Naproxen works by reducing hormones that cause inflammation and pain in the body.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of naproxen and pseudoephedrine is used to treat stuffy nose, sinus congestion, cough, and pain or fever caused by the common cold or flu.

Naproxen and pseudoephedrine may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of naproxen and pseudoephedrine (Aleve Cold and Sinus, Aleve Sinus & Headache)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking naproxen and pseudoephedrine and seek medical attention or call your doctor at once if you have any of these serious side effects:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
• black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• fast, pounding, or uneven heartbeat;
• severe dizziness, anxiety, restless feeling, or nervousness;
• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;
• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
• urinating less than usual or not at all;
• skin rash, bruising, severe tingling, numbness, pain, muscle weakness; or
• fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

Keep taking naproxen and pseudoephedrine and talk to your doctor if you have any of these less serious side effects:

• upset stomach, nausea, heartburn, diarrhea, constipation;
• bloating, gas, loss of appetite;
• warmth, tingling, or redness under your skin;
• dizziness, headache, feeling excited or restless;
• sleep problems (insomnia);
• skin rash or itching;
• skin itching or rash; or
• ringing in your ears.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about naproxen and pseudoephedrine (Aleve Cold and Sinus, Aleve Sinus & Headache)?

Do not use naproxen and pseudoephedrine 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.

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

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

Naproxen 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 can occur without warning at any time while you are taking naproxen.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not take more of this medication than is recommended. An overdose of naproxen can cause damage to your stomach or intestines.

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