Naproxen and pseudoephedrine

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

Naproxen and pseudoephedrine is a combination medicine used to treat a 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 reasons not mentioned in this medication guide.

Use exactly as directed on the label, or as prescribed by your doctor. Use the lowest dose that effectively treats your condition.

Swallow the tablet whole and do not crush, chew, or break it.

Take this medicine with a full glass of water.

Take with food or milk if this medicine makes your stomach upset.

If you need to have any type of surgery, inform the surgeon ahead of time if you have taken this medicine in the past few days.

Call your doctor if you have a fever lasting longer than 3 days, or if your symptoms do not improve after 7 days of taking this medicine.

Store at room temperature away from moisture and heat.

Naproxen can raise your chances of having a fatal heart attack or stroke. Do not use this medicine right before or after heart bypass surgery (coronary artery bypass graft, or CABG). Naproxen may also lead to stomach or intestinal bleeding, which can be deadly.

Naproxen can raise your chances of having a fatal heart attack or stroke, even if you do not have any risk factors. Do not use naproxen and pseudoephedrine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Naproxen may also lead to stomach or intestinal bleeding, which can be fatal. These issues can happen suddenly while you are taking naproxen, especially in older adults.

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

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

Ask a doctor or pharmacist if this medicine is safe for you 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 advises you to. Taking an NSAID in the last 20 weeks can harm the unborn baby or lead to pregnancy complications.

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

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

Get emergency medical help if you have signs of an allergic reaction (hives, trouble 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.

naproxen and pseudoephedrine may cause serious side effects. Stop using naproxen and pseudoephedrine and call your doctor right away 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 of naproxen and pseudoephedrine 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.

Usual Adult Dose for Nasal Congestion:

Naproxen 220 mg/ pseudoephedrine 120 mg per tablet: 1 tablet orally every 12 hours:Maximum dose: 2 tablets per 24 hours

Usual Adult Dose for Analgesic/Antipyretic:

Naproxen 220 mg/ pseudoephedrine 120 mg per tablet: 1 tablet orally every 12 hours:Maximum dose: 2 tablets per 24 hours

Usual Pediatric Dose for Nasal Congestion:

Naproxen 220 mg/ pseudoephedrine 120 mg per tablet:12 years and older: 1 tablet orally every 12 hours:Maximum dose: 2 tablets per 24 hours

Usual Pediatric Dose for Analgesic/Antipyretic:

Naproxen 220 mg/ pseudoephedrine 120 mg per tablet:12 years and older: 1 tablet orally every 12 hours:Maximum dose: 2 tablets per 24 hours

Since cold medicine is taken as needed, you might not follow a set dosing schedule. If you miss a dose and it's nearly time for your next one, just skip the missed dose. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• 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.

Ask your doctor before using naproxen and pseudoephedrine if you take an antidepressant. Taking certain antidepressants with an NSAID may make you bruise or bleed easily.

Ask a doctor or pharmacist before using naproxen and pseudoephedrine with any other medications, especially:

• a blood thinner (warfarin, Coumadin, Jantoven);
• heart or blood pressure medication, including a diuretic or "water pill"; or
• steroid medicine (such as prednisone).

This list is not complete. Other drugs may affect naproxen and pseudoephedrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.