Skip to Content

Naproxen and pseudoephedrine

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, Aleve Sinus & Headache, Aleve-D Cold and Sinus, Aleve-D Sinus & Cold, Sudafed Sinus & Pain 12 Hour, Sinus & Cold-D

Medically reviewed on November 6, 2017

What is naproxen and pseudoephedrine?

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).

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.

Important Information

Do not use naproxen and pseudoephedrine 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 naproxen and pseudoephedrine, 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:

Taking naproxen during the last 3 months of pregnancy may harm the unborn baby. Do not use naproxen and pseudoephedrine 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.

Naproxen and pseudoephedrine is not approved for use by anyone younger than 12 years old.

How should I take naproxen and pseudoephedrine?

Use exactly as directed on the label, or as prescribed by your doctor. Do not take naproxen and pseudoephedrine 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 naproxen and pseudoephedrine?

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

Avoid taking aspirin while you are taking naproxen and pseudoephedrine.

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.

Naproxen and pseudoephedrine 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 naproxen and pseudoephedrine 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:

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.

See also: Side effects (in more detail)

Naproxen and pseudoephedrine dosing information

Usual Adult Dose for Nasal Congestion:

Extended-release: naproxen 220 mg-pseudoephedrine 120 mg orally every 12 hours.

Usual Adult Dose for Analgesic/Antipyretic:

Extended-release: naproxen 220 mg-pseudoephedrine 120 mg orally every 12 hours.

Usual Pediatric Dose for Nasal Congestion:

12 years or older:
Extended-release: naproxen 220 mg-pseudoephedrine 120 mg orally every 12 hours.

Usual Pediatric Dose for Analgesic/Antipyretic:

12 years or older:
Extended-release: naproxen 220 mg-pseudoephedrine 120 mg orally every 12 hours.

What other drugs will affect naproxen and pseudoephedrine?

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 naproxen and pseudoephedrine if you are also using any of the following drugs:

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.

Further information

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.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide