Naproxen/Pseudoephedrine, Oral

________________________________________________________________________

KEY POINTS

• This medicine is taken by mouth to relieve pain, fever, and nasal, sinus and ear congestion. Take it exactly as directed.
• NSAIDs may increase the chance of a heart attack or stroke that can lead to death. This medicine may cause ulcers and bleeding in the stomach and intestines at any time during treatment. This medicine should not be used right before or after a heart surgery called coronary artery bypass graft (CABG).
• This medicine may also cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

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

Generic and brand names: naproxen/pseudoephedrine, oral; Aleve-D Cold and Sinus; Aleve-D Sinus and Headache; Sudafed 12 Hour Pressure+Pain (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, flu, sinusitis, or allergies such as hay fever.

This medicine may be used to treat 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 or transient ischemic attack (TIA)
• Asthma
• Bleeding problems or blood disorders such as anemia
• Diabetes
• Glaucoma
• Heart disease
• High blood pressure
• Kidney or liver disease
• Nasal polyps
• Thyroid problems
• Trouble urinating or an enlarged prostate gland
• Ulcers

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, congestion, 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 3 days for fever or 7 days for congestion without your healthcare provider's approval. Ask your provider or pharmacist about anything you do not understand.

Check with your healthcare provider before using this medicine in children under age 12.

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: This medicine may cause ulcers and bleeding in the stomach and intestines at any time during treatment. This may happen without warning symptoms. If you have stomach pain, or bloody or black tarry bowel movements, stop taking this medicine and contact your healthcare provider right away.

NSAIDs may increase the chance of a heart attack or stroke that can lead to death. This chance increases if you:

• Use NSAIDs for a long time
• Have heart disease

Talk with your healthcare provider about this.

Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

This medicine may cause an allergic reaction in people who have asthma or who have had allergic reactions to aspirin or other pain medicines. 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 medicines 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, lab tests, 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 bowel movements; severe vomiting; irregular heartbeat; fast breathing; trouble urinating; blood in urine; unusual bruising or bleeding; 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, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), moexipril (Univasc), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik)
• Aliskiren (Tekturna) and aliskiren/hydrochlorothiazide (Tekturna HCT)
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antibiotics such as ciprofloxacin (Cipro), levofloxacin (Levaquin), and moxifloxacin (Avelox)
• Antidepressants such as amitriptyline, desipramine (Norpramin), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), venlafaxine (Effexor)
• Aspirin and other salicylates
• Beta blockers such as atenolol (Tenormin), bisoprolol (Zebeta), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), nebivolol (Bystolic), and timolol
• Caffeine and stimulants such as armodafinil (Nuvigil), atomoxetine (Strattera), benzphetamine (Regimex), dexmethylphenidate (Focalin), dextroamphetamine (Dexedrine), diethylpropion (Tenuate), methamphetamine (Desoxyn), methylphenidate (Concerta, Daytrana, Metadate, Ritalin), modafinil (Provigil), and phentermine (Adipex-P, Suprenza)
• Cholesterol-lowering medicines such as cholestyramine (Prevalite) and colestipol (Colestid)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Dasatinib (Sprycel)
• Diabetes medicines such as glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), pioglitazone (Actos), and rosiglitazone (Avandia)
• Digoxin (Lanoxin)
• Diuretics (water pills) such as bumetanide, chlorothiazide (Diuril), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), and torsemide (Demadex)
• Doxepin (Silenor)
• Galantamine (Razadyne)
• HIV medicines such as tenofovir (Viread) and tipranavir (Aptivus)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and tacrolimus (Astagraf, Prograf, Protopic)
• Linezolid (Zyvox)
• Lithium (Lithobid)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to treat or prevent blood clots such as abciximab (ReoPro), apixaban (Eliquis), argatroban, bivalirudin (Angiomax), clopidogrel (Plavix), dabigatran (Pradaxa), dipyridamole (Persantine), edoxaban (Savaysa), lepirudin (Refludan), prasugrel (Effient), rivaroxaban (Xarelto), ticagrelor (Brilinta), tirofiban (Aggrastat), and warfarin (Coumadin)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Methyldopa
• Migraine medicines such as dihydroergotamine (D.H.E. 45, Migranal) and ergotamine (Ergomar)
• Natural remedies such as alfalfa, anise, bilberry, chaparral, comfrey, ephedra, feverfew, fish oil, flaxseed, garlic, ginkgo, ginseng, glucosamine, green tea, kava, ma huang, pennyroyal, valerian, and yohimbe
• Osteoporosis medicines such as alendronate (Fosamax), ibandronate (Boniva), and risedronate (Actonel, Atelvia)
• Other nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, meloxicam (Mobic), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Pentosan (Elmiron)
• Probenecid
• Procarbazine (Matulane)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Raloxifene (Evista)
• Reserpine
• Theophylline

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

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. 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.