Sudafed Sinus 12 Hour Pressure + Pain

Naproxen is a type of medicine called a nonsteroidal anti-inflammatory drug (NSAID). Pseudoephedrine is a medicine that helps relieve stuffiness.

Sudafed Sinus 12 Hour Pressure + Pain is a combination medicine used to relieve a stuffy nose, sinus congestion, headache, fever, and minor aches and pains caused by the common cold or flu.

Sudafed Sinus 12 Hour Pressure + Pain may also be used for other reasons that are not mentioned in this medication guide.

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

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

Take this medicine with a full glass of water.

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

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

Call your doctor if you have a fever that lasts more than 3 days, or if your symptoms do not improve after taking this medicine for 7 days.

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 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 life-threatening.

Naproxen can raise your chances of having a fatal heart attack or stroke, even if you have no risk factors. Do not use Sudafed Sinus 12 Hour Pressure + Pain 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 deadly. These issues can happen without warning while you are taking naproxen, particularly 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 serious allergic reaction after taking aspirin or an NSAID.

Do not use Sudafed Sinus 12 Hour Pressure + Pain 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 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 consume 3 or more alcoholic drinks each day.

Do not use Sudafed Sinus 12 Hour Pressure + Pain during pregnancy unless your doctor advises you to. Using an NSAID in the last 20 weeks of pregnancy can harm the unborn baby or cause complications.

Consult 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, difficulty 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 Sudafed Sinus 12 Hour Pressure + Pain 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 of Sudafed Sinus 12 Hour Pressure + Pain 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.

Since cold medicine is taken as needed, you may not have a regular dosing schedule. If you miss a dose and it’s almost time for your next dose, just skip the missed dose. Do not take two doses at the same time.

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 Sudafed Sinus 12 Hour Pressure + Pain if you take an antidepressant. Taking some antidepressants with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist before using Sudafed Sinus 12 Hour Pressure + Pain 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 Sudafed Sinus 12 Hour Pressure + Pain, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.