Naproxen; Pseudoephedrine oral tablets

What is this medication?

NAPROXEN; PSEUDOEPHEDRINE (na PROX en; soo doe e FED rin) is a combination of pain reliever and a decongestant. It is used to treat the aches, pains, and congestion of a cold. This medicine will not treat an infection.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Aleve Cold and Sinus, Aleve Sinus & Cold, Aleve Sinus & Headache, Aleve Sinus Headache, Aleve-D 12 Hour Sinus & Cold, Aleve-D 12 Hour Sinus & Headache, Sudafed 12 hour Pressure + Pain, Sudafed Sinus and Pain 12 hour

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• bleeding problems
• diabetes
• heart disease or surgery
• high blood pressure
• if you frequently drink alcohol containing drinks
• kidney disease
• low salt diet
• stomach problems like heartburn or ulcer
• taken an MAOI like Eldepryl, Marplan, Nardil, or Parnate in last 14 days
• thyroid disease
• trouble passing urine
• an unusual or allergic reaction to naproxen, pseudoephedrine, aspirin, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Do not cut, crush or chew this medicine. Take your medicine at regular intervals. Do not take it more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 years old for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

•bromocriptine

•cidofovir

•cocaine

•ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine

•ketorolac

•MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

•methotrexate

•pemetrexed

•stimulant medicines for attention disorders, weight loss, or to stay awake

This medicine may also interact with the following medications:

•alcohol

•alendronate

•aspirin and aspirin-like medicines

•atomoxetine

•bretylium

•cyclopropane

•digoxin

•dyphylline

•flavocoxid

•furazolidone

•ginkgo, Ginkgo biloba

•medicines for sleep during surgery

•linezolid

•medicines for blood pressure, chest pain, heart disease, irregular heart beat

•medicines for depression, anxiety, or psychotic disturbances

•medicines that treat or prevent blood clots like warfarin

•NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen

•other medicines for allergy, cough, cold, fever or pain

•other medicine that contains naproxen or pseudoephedrine

•pamidronate

•probenecid

•procarbazine

•St. John's Wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your doctor or health care provider if your symptoms do not start to get better or if they get worse. Let your doctor know if you have pain or nasal congestion that gets worse or lasts for more than 7 days. Call your doctor if you have a fever that gets worse or lasts for more than 3 days.

Do not take other medicines that contain aspirin, ibuprofen, or naproxen with this medicine. Side effects such as stomach upset, nausea, or ulcers may be more likely to occur. Many non-prescription medicines contain aspirin, ibuprofen, or naproxen. Always read labels carefully.

This medicine can cause serious ulcers and bleeding in the stomach. It can happen with no warning. Smoking, drinking alcohol, older age, and poor health can also increase risks. Call your health care provider right away if you have stomach pain or blood in your vomit or stool.

This medicine does not prevent a heart attack or stroke. This medicine may increase the chance of a heart attack or stroke. The chance may increase the longer you use this medicine or if you have heart disease. If you take aspirin to prevent a heart attack or stroke, talk to your health care provider about using this medicine.

Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your health care provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

Talk to your health care provider if you are pregnant before taking this medicine. Taking this medicine between weeks 20 and 30 of pregnancy may harm your unborn baby. Your health care provider will monitor you closely if you need to take it. After 30 weeks of pregnancy, do not take this medicine.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

This medicine may make it more difficult to get pregnant. Talk to your health care provider if you are concerned about your fertility.

Talk to your doctor if you need to use this medicine for more than 7 days. Using this medicine every day for a long time may increase your risk of heart attack or stroke.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care provider as soon as possible:

• allergic reactions (skin rash, itching or hives, swelling of the face, lips, or tongue)
• bloody, black or tarry stools
• changes in hearing
• changes in vision
• chest pain, tightness
• dark urine
• dizziness, nervousness, or sleeplessness
• fast, irregular heartbeat
• feeling faint or lightheaded, falls
• heartburn
• rash, fever, and swollen lymph nodes
• redness, blistering, peeling, or loosening of the skin, including inside the mouth
• swelling of the ankles, feet, legs
• trouble passing urine or change in the amount of urine
• trouble swallowing
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation
• diarrhea
• dry eyes, mouth
• loss of appetite
• stomach upset

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F).

Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.