Naproxen/Pseudoephedrine, Oral

What are other names for this medicine?

Type of medicine: nonsteroidal anti-inflammatory drug (NSAID); decongestant

Generic and brand names: naproxen/pseudoephedrine, oral; Aleve Cold and Sinus; Aleve Sinus and Headache (There may be other brand names for this medicine.)

What is this medicine used for?

This medicine is combines a nonsteroidal anti-inflammatory drug (NSAID) with a decongestant. It is used to provide relief from:

• pain and fever
• nasal, sinus, and ear congestion due to infections, colds, sinusitis, or allergies such as hay fever.

This medicine may be used for other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before you take this medicine, be sure to tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• a stroke
• asthma
• bleeding problems or blood disorders such as anemia
• diabetes
• glaucoma
• heart disease
• high blood pressure
• kidney or liver disease
• nasal polyps
• an enlarged prostate or problems urinating
• stomach or intestinal ulcers or bleeding
• thyroid problems

Do not take this medicine if you have taken an MAO inhibitor antidepressant within the last 14 days. Tell your provider if you take steroids such as prednisone or medicine that reduces the chance of blood clots forming such as warfarin (Coumadin).

Females of childbearing age: Tell your healthcare provider if you are pregnant or breast-feeding. This medicine is not recommended for use in late pregnancy because it may harm the baby. Do not breast-feed while you are taking this medicine.

How do I use it?

Take this medicine with a full glass (8 ounces) of water. You may take this medicine with or without food. Taking it with food, milk, or antacids may lessen the chance the drug will upset your stomach. Do not break, crush, or chew this medicine. Swallow it whole.

You can buy this medicine without a prescription to relieve pain and fever. Take it according to the directions on the package. Do not take more medicine or take it more often than directed. Do not take this medicine for more than 10 days without your healthcare provider's approval. Ask your provider or pharmacist about anything you do not understand.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nausea, vomiting, stomach pain, dizziness, restlessness, nervousness, blurred vision, sweating, trouble breathing, seizures.

What should I watch out for?

Warning: Occasionally, this medicine may cause bleeding, ulcers, or perforation of the stomach or intestines. These problems may occur without warning symptoms. If you have abdominal pain, a black tarry stool, or a bloody stool, stop taking this medicine and contact your healthcare provider right away.

Taking this medicine for a long time may make it more likely that you will have a heart attack or stroke. Talk with your healthcare provider about this.

This medicine may cause an allergic reaction in people who have asthma or who have had allergic reactions to aspirin or other painkillers. If you develop hives, itching, a rash, tightness in your chest, or trouble breathing, stop taking this medicine and contact your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.

Contact your healthcare provider if your symptoms do not improve in 7 days, if you develop a high fever, or if your symptoms get worse.

Do not take other pain relievers or drink alcohol while you are taking this medicine unless your healthcare provider approves. They may increase the risk of stomach upset.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

This medicine may make your skin more sensitive to the sun, which may lead to painful sunburns. Wear protective clothing, a hat, and sunscreen lotion when you need to be outdoors.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives, itching, rash, tightness in your chest or trouble breathing); extreme headache with stiff neck; seizures.

Serious (report these to your healthcare provider right away): Confusion; feeling faint; mouth or lip sores; hearing problems or ringing in your ears; vision changes; yellowing of your skin or eyes; bloody or black tarry stools; severe vomiting; irregular heartbeat; fast breathing; trouble urinating; blood in urine; unusual bleeding or bruising; swelling in hands or feet.

Other: Fever, chills, muscle pain, stomach pain, diarrhea, nausea, tiredness, gas, headache, dizziness, drowsiness, constipation, nervousness, trouble sleeping.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), trandolapril (Mavik), and moexipril (Univasc)
• alcohol
• angiotensin II blockers such as candesartan (Atacand), losartan (Cozaar), and valsartan (Diovan)
• aspirin and aspirin containing products such as Fiorinal, St. Joseph's, Aggrenox
• antiseizure medicines such as phenytoin (Dilantin) and fosphenytoin (Cerebyx)
• beta blockers such as metoprolol (Lopressor, Toprol XL), atenolol (Tenormin), bisoprolol (Zebeta), timolol, propranolol (Inderal, Inderal LA), and nadolol (Corgard)
• bile acid sequestrants such as cholestyramine (Questran), colesevelam (WelChol), and colestipol (Colestid)
• caffeine or stimulants such as diet pills
• celecoxib (Celebrex)
• corticosteroids such as prednisone and methylprednisolone (Medrol, Solu-Medrol)
• diabetes medicines such as insulin, glyburide (DiaBeta, Glynase, Micronase), metformin (Glucophage, Glucovance), pioglitazone (Actos), and rosiglitazone (Avandia)
• digoxin (Lanoxin)
• diuretics such as furosemide (Lasix), bumetanide (Bumex), ethacrynic acid (Edecrin), chlorothiazide (Diuril), and hydrochlorothiazide (Microzide)
• immunosuppressants such as cyclosporine (Sandimmune, Neoral, Gengraf), and tacrolimus (Prograf)
• linezolid (Zyvox)
• lithium (Lithobid, Eskalith)
• MAO inhibitor antidepressants such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate) (Do not take an MAO inhibitor and this medicine within 14 days of each other.)
• medicines to treat Alzheimer's such as galantamine (Razadyne ER and Razadyne) and tacrine (Cognex)
• medicine that reduces the chance of blood clots forming such as warfarin (Coumadin), abciximab (ReoPro), argatroban, lepirudin (Refludan), bivalirudin (Angiomax), tirofiban (Aggrastat), pentosan polysulfate sodium (Elmiron), clopidogrel (Plavix), ticlopidine (Ticlid), and dipyridamole (Persantine)
• methotrexate
• methyldopa (Aldomet)
• migraine medicines such as ergotamine (Bel Tabs, Bellamine S, Cafergot, Ergomar) and dihydroergotamine (D.H.E. 45, Migranal)
• natural remedies such as chaparral, comfrey, ephedra, feverfew, flaxseed, fish oil, garlic, ginseng, ginkgo, green tea, kava, ma huang, pennyroyal, valerian, and yohimbe
• other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Motrin, Motrin IB, Advil, Nuprin), ketoprofen, nabumetone (Relafen), indomethacin (Indocin), ketorolac (Toradol), sulindac (Clinoril), piroxicam (Feldene), diclofenac (Voltaren, Cataflam), and oxaprozin (Daypro)
• pentosan polysulfate sodium (Elmiron)
• probenecid (Benemid)
• procarbazine (Matulane)
• quinolone antibiotics such as levofloxacin (Levaquin), ofloxacin (Floxin), ciprofloxacin (Cipro), gatifloxacin (Tequin), and moxifloxacin (Avelox)
• raloxifene hydrochloride (Evista)
• reserpine
• SSRI antidepressants such as sertraline (Zoloft), fluoxetine (Prozac), paroxetine (Paxil), citalopram (Celexa), and escitalopram (Lexapro)
• theophylline

Do not drink alcohol while taking this medicine. Also, do not take other painkillers while you are taking this medicine without your healthcare provider's approval.

Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.