Generic Name: naproxen and pseudoephedrine (na PROX en and soo doe e FED rin)Brand Names: Aleve Cold and Sinus
Naproxen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). 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).
The combination of naproxen and pseudoephedrine is used to treat stuffy nose, sinus congestion, cough, and pain or fever caused by the common cold or flu.
Naproxen and pseudoephedrine may also be used for purposes other than those listed in this medication guide.What is the most important information I should know about Aleve Cold and Sinus (naproxen and pseudoephedrine)?Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use naproxen and pseudoephedrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.
Naproxen can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).
Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.
Naproxen can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning at any time while you are taking naproxen.
Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.Do not take more of this medication than is recommended. An overdose of naproxen can cause damage to your stomach or intestines.What should I discuss with my healthcare provider before taking Aleve Cold and Sinus (naproxen and pseudoephedrine)?Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take a cough or cold medicine before the MAO inhibitor has cleared from your body.
Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).
NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.Do not use this medication if you are allergic to naproxen and pseudoephedrine, or if you have a history of allergic reaction to aspirin or other NSAIDs.
Before taking naproxen and pseudoephedrine, tell your doctor if you are allergic to any drugs, or if you have:
a history of heart attack, stroke, or blood clot;
heart disease, congestive heart failure, high blood pressure;
a history of stomach ulcers or bleeding;
a thyroid disorder;
polyps in your nose;
a bleeding or blood clotting disorder; or
if you smoke.
If you have any of these conditions, you may not be able to use naproxen and pseudoephedrine, or you may need a dosage adjustment or special tests during treatment.This medication may be harmful to an unborn baby. Taking naproxen during the last 3 months of pregnancy may result in birth defects. Do not take naproxen and pseudoephedrine during pregnancy unless your doctor has told you to. Naproxen and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. The extended-release pill is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time. Call your doctor if you have a fever lasting longer than 3 days, if you have new symptoms, or if your condition does not improve after taking this medication for 7 days.
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.Store naproxen and pseudoephedrine at room temperature away from moisture and heat.
Since cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Symptoms of a naproxen and pseudoephedrine overdose may include nausea, vomiting, stomach pain, dizziness, feeling restless or nervous, blurred vision, sweating, breathing problems, or seizure (convulsions).What should I avoid while taking Aleve Cold and Sinus (naproxen and pseudoephedrine)?Do not use any other over-the-counter cough, cold, or pain medication without first asking your doctor or pharmacist. Naproxen and pseudoephedrine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of either medication. Read the label of any other medicine you are using to see if it contains naproxen or pseudoephedrine. Avoid drinking alcohol while taking naproxen and pseudoephedrine. If you drink more than 3 alcoholic beverages a day, naproxen may increase your risk of stomach bleeding.
chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
fast, pounding, or uneven heartbeat;
severe dizziness, anxiety, restless feeling, or nervousness;
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
urinating less than usual or not at all;
skin rash, bruising, severe tingling, numbness, pain, muscle weakness; or
fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).
Keep taking naproxen and pseudoephedrine and talk to your doctor if you have any of these less serious side effects:
upset stomach, nausea, heartburn, diarrhea, constipation;
bloating, gas, loss of appetite;
warmth, tingling, or redness under your skin;
dizziness, headache, feeling excited or restless;
sleep problems (insomnia);
skin rash or itching;
skin itching or rash; or
ringing in your ears.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.What other drugs will affect Aleve Cold and Sinus (naproxen and pseudoephedrine)?
Before taking naproxen and pseudoephedrine, tell your doctor if you are taking any of the following drugs:
a blood thinner such as warfarin (Coumadin);
diuretics (water pills), or blood pressure medications;
steroids (prednisone and others);
aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as diclofenac (Cataflam, Voltaren), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), piroxicam (Feldene), and others;
an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others;
a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or
antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.
If you are using any of these drugs, you may not be able to use naproxen and pseudoephedrine or you may need dosage adjustments or special tests during treatment.
There may be other drugs not listed that can affect naproxen and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.