Generic Name: naproxen and pseudoephedrine (na PROX en and soo doe e FED rin)
Brand Name: Aleve Cold and Sinus, Aleve Sinus & Headache, Aleve-D Sinus & Cold, Sudafed PSE
What is Sudafed PSE?
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). 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).
Sudafed PSE 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.
Sudafed PSE may also be used for purposes not listed in this medication guide.
Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.
Naproxen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. 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.
Before taking this medicine
Naproxen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.
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 Sudafed PSE, 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.
Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions, especially:
heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
a history of heart attack, stroke, or blood clot;
a history of stomach ulcers or bleeding;
a thyroid disorder;
enlarged prostate, urination problems;
liver or kidney disease; or
Taking naproxen during the last 3 months of pregnancy may harm the unborn baby. Do not use Sudafed PSE without a doctor's advice if you are pregnant.
Naproxen can pass into breast milk and may harm a nursing baby. Ask a doctor before using this medicine if you are breast-feeding.
Sudafed PSE is not approved for use by anyone younger than 12 years old.
How should I take Sudafed PSE?
Use exactly as directed on the label, or as prescribed by your doctor. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.
Do not crush, chew, or break the tablet. Swallow it whole.
Take this medicine with a full glass of water.
Take with food or milk if this medicine upsets your stomach.
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.
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.
What happens if I miss a dose?
Since cold medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Sudafed PSE?
Avoid drinking alcohol. It may increase your risk of stomach bleeding.
Avoid taking aspirin while you are taking Sudafed PSE.
Ask a doctor or pharmacist before using any other cold, allergy, or pain medicine. Many medicines available over the counter contain naproxen, pseudoephedrine, or similar medicines. Taking certain products together can cause you to get too much of these medicines.
Sudafed PSE side effects
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, 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, anxiety, or nervousness;
shortness of breath (even with mild exertion);
swelling or rapid weight gain;
the first sign of any skin rash, no matter how mild;
signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
liver problems--loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.
Common side effects may include:
indigestion, heartburn, stomach pain, nausea;
warmth, tingling, or redness under your skin;
sleep problems (insomnia); or
feeling restless 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.
What other drugs will affect Sudafed PSE?
Ask your doctor before using this medicine if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.
Ask a doctor or pharmacist if it is safe for you to use Sudafed PSE if you are also using any of the following drugs:
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 interact with naproxen and pseudoephedrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
More about naproxen/pseudoephedrine
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- Support Group
- 1 Review – Add your own review/rating
- Drug class: upper respiratory combinations
Related treatment guides
Where can I get more information?
- Your pharmacist can provide more information about Sudafed PSE.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
- Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2012 Cerner Multum, Inc. Version: 3.01.
Date modified: January 03, 2018
Last reviewed: November 06, 2017