Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). Pseudoephedrine is a decongestant.

Naproxen and pseudoephedrine is a combination medicine used to treat stuffy nose, sinus congestion, headache, fever, and minor aches and pains caused by the common cold or flu.

Naproxen and pseudoephedrine may also be used for purposes not listed in this medication guide.

Naproxen can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using naproxen, especially in older adults.

You should not use this medicine if you are allergic to naproxen or pseudoephedrine, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Do not use naproxen and pseudoephedrine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

Ask a doctor or pharmacist if this medicine is safe to use if you have:

• heart disease, high blood pressure, diabetes;
• a heart attack or stroke;
• a stomach ulcer or bleeding;
• asthma;
• a thyroid disorder;
• enlarged prostate, urination problems;
• liver or kidney disease; or
• if you drink 3 or more alcoholic drinks per day.

Do not use naproxen and pseudoephedrine during pregnancy unless your doctor tells you to. Using an NSAID in the last 20 weeks can harm the unborn baby or cause pregnancy complications.

Ask a doctor before using this medicine if you are breastfeeding.

Not approved for use by anyone younger than 12 years old.

Use Sinus & Cold-D (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, feeling light-headed, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Stop using this medicine and call your doctor at once if you have:

• severe dizziness or nervousness, trouble sleeping;
• swelling, rapid weight gain;
• shortness of breath;
• new or worsening stomach pain; or
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects may include:

• heartburn, stomach pain, nausea, vomiting;
• dizziness;
• sleep problems (insomnia); or
• feeling nervous or excited.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin unless your doctor tells you to.

Ask a doctor or pharmacist before using other cough or cold medicines that may contain similar ingredients.