naproxen / pseudoephedrine
Aleve-D Sinus and Cold is a combination of naproxen (a non-steroidal anti-inflammatory drug, or NSAID) and pseudoephedrine (a decongestant). It's used to treat symptoms of cold or flu, such as stuffy nose, headache, and fever. Aleve-D (naproxen / pseudoephedrine) is taken by mouth every 12 hours as needed and can be used by adults and children 12 years and older. Some side effects of this medication include restlessness, nausea, and stomach upset. Other brand names of this medication include Sudafed Sinus 12 Hour Pressure + Pain.
What is Aleve-D (naproxen / pseudoephedrine)?
What is Aleve-D (naproxen / pseudoephedrine) used for?
Short-term relief of symptoms due to the common cold or flu:
Sinus congestion and pressure
Headache
Body aches and pains
Fever
How Aleve-D (naproxen / pseudoephedrine) works
Aleve-D (naproxen / pseudoephedrine) is a combination of two medications:
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking proteins from making chemicals called prostaglandins, which are responsible for pain and swelling. In doing so, this medication eases pain and swelling.
Pseudoephedrine is a decongestant. It makes the blood vessels around your nose more narrow, which eases nasal swelling and pressure.
Drug Facts
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What are the side effects of Aleve-D (naproxen / pseudoephedrine)?
Common Side Effects
- Restlessness
- Trouble sleeping
- Headache
- Nausea
- Heartburn
- Stomach pain
- Constipation
- Nausea
- Headache
- Dizziness
- Feeling drowsy
- Itching
- Ringing in the ear
- Swelling
Serious Side Effects
- Heart attack: trouble breathing, chest pain or tightness
- Stroke: blurred vision, difficulty speaking, difficulty walking, weakness on one side of the body
- Stomach bleeds: blood in your vomit, stool that looks like black coffee grounds, pain in your stomach that doesn't go away
- Serious allergic or skin reaction: fever, body aches, cough, peeling skin, rash, trouble breathing, swelling of the face, painful blisters all over your body
- Dangerously high blood pressure: headache, shortness of breath, changes in vision, light-headedness, fatigue
- Serious kidney problems: tiredness, dry and itchy skin, low appetite, urinating less than usual, foamy or bloody urine, muscle cramps
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
- Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
- Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
- Heart palpitations—rapid, pounding, or irregular heartbeat
- Increase in blood pressure
- Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Rash, fever, and swollen lymph nodes
- Redness, blistering, peeling, or loosening of the skin, including inside the mouth
- Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Anxiety, nervousness
- Headache
- Loss of appetite
- Nausea
- Trouble sleeping
- Upset stomach
Pros and cons of Aleve-D (naproxen / pseudoephedrine)
Pros
Taken by mouth
Works within 30 minutes for stuffy nose and sinus congestion
Combines two medications into one product for convenience
Pharmacist tips for Aleve-D (naproxen / pseudoephedrine)
Make sure to take Aleve-D (naproxen / pseudoephedrine) with food or milk since it can cause damage to your stomach, causing belly pain, bleeding, or irritation.
Stop taking Aleve-D (naproxen / pseudoephedrine) and contact your provider if your fever lasts more than 3 days or if your stuffy nose lasts more than 7 days. These might be signs of a serious health condition that needs to be treated with appropriate medications.
If you have a history of liver or kidney problems, high blood pressure, heart problems, asthma, diabetes, or other medical conditions, ask your provider if it's safe for you to take Aleve-D (naproxen / pseudoephedrine). This is because Aleve-D (naproxen / pseudoephedrine) can sometimes worsen these medical conditions.
Avoid taking Aleve-D (naproxen / pseudoephedrine) if you're pregnant or plan to become pregnant. This is because naproxen can cause harm to your unborn baby, especially at or after 20 weeks. If you need medication to help with pain, ask your provider about safer alternatives during pregnancy.
Aleve-D (naproxen / pseudoephedrine) should be stored up and away and out of children's reach and sight. This prevents them from accidentally swallowing medication that's left out. Always put medication away every time you use it. If you think that your child might’ve accidentally swallowed Aleve-D (naproxen / pseudoephedrine), call your Poison Control Center at 1-800-222-1222 right away even if you aren't completely sure.
Let your provider or pharmacist know what medications you're taking, including over-the-counter products and supplements, before you start Aleve-D (naproxen / pseudoephedrine). They can help screen for interactions.
If you're taking aspirin for your heart and your provider said it's safe to also take Aleve-D (naproxen / pseudoephedrine), make sure to take aspirin at least 2 hours before Aleve-D (naproxen / pseudoephedrine). Taking both medications at the same time will lower the amount of aspirin your body will absorb.
If you're allergic to aspirin or other NSAIDs, talk to your provider or pharmacist before starting Aleve-D (naproxen / pseudoephedrine) because you might be allergic to this medication as well.
Frequently asked questions about Aleve-D (naproxen / pseudoephedrine)
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What are the risks and warnings for Aleve-D (naproxen / pseudoephedrine)?
Aleve-D (naproxen / pseudoephedrine) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Severe allergic reactions
Risk factor: History of allergy to aspirin or other NSAIDs
Although rare, it's possible to have a severe and life-threatening allergic reaction to Aleve-D (naproxen / pseudoephedrine). The risk is higher if you're allergic to aspirin, a similar painkiller to naproxen in Aleve-D (naproxen / pseudoephedrine). These allergic reactions can include hives, facial swelling, and wheezing. Aleve-D (naproxen / pseudoephedrine) can also cause severe skin reactions, such as reddening or peeling of the skin, painful rash, and fluid-filled blisters. Stop taking Aleve-D (naproxen / pseudoephedrine) and go to the emergency room right away if you experience any of these symptoms.
Stomach bleeding and ulcers
Risk factors: Age 60 years or older | History of stomach bleeding or ulcers | Taking other medications that can cause stomach problems | More than 3 alcoholic drinks daily| Bleeding problems | Taking naproxen for a long time | Taking higher doses of naproxen
Naproxen in Aleve-D (naproxen / pseudoephedrine) can cause stomach bleeding and ulcers. These problems can occur without warning or symptoms, so it's best to take the lowest dose for the shortest possible time to minimize your risk. Some medications, such as oral corticosteroids and blood thinners, can raise your risk of stomach bleeding. Tell your provider about all the medications that you take before starting Aleve-D (naproxen / pseudoephedrine). If you have severe stomach pain, black and tarry stools, or blood in the urine while using this medication, get medical help promptly. Also, get medical help if you fall and hit your head or experience other injuries, your provider might want to examine you to make sure you're not bleeding on the inside.
Heart attack and stroke
Risk factors: History of heart problems| | Recent history of heart bypass surgery | High blood sugar | High cholesterol | Smoking | Taking high doses of naproxen | Taking naproxen for a long time
NSAIDs, like naproxen in Aleve-D (naproxen / pseudoephedrine), can raise your risk of having blood clots, heart attacks, or strokes. The risk might be higher if you have a history of heart problems, use this medication at higher doses, or use this medication for a long period of time. To prevent heart attack or stroke from happening, your provider will prescribe the lowest possible dose of Aleve-D (naproxen / pseudoephedrine) for the shortest amount of time that works well for you. If you have heart problems, talk to your healthcare provider before starting this medication. Don't use Aleve-D (naproxen / pseudoephedrine) if you've had or will be having heart bypass surgery. Call 911 or get immediate medical help if you experience chest pain, trouble breathing, weakness on one side of your body, or trouble speaking or walking.
High blood pressure and heart failure
Risk factors: Heart problems
Aleve-D (naproxen / pseudoephedrine) can cause your body to hold onto extra fluid, which can raise your blood pressure or put you at risk for heart failure. Tell your provider if you have a history of heart problems, or are taking blood pressure medications, before starting Aleve-D (naproxen / pseudoephedrine) to make sure it's safe for you. Your provider will screen you for heart problems before starting you on this medication. Some forms of Aleve-D (naproxen / pseudoephedrine) contains sodium, so it's important to keep track of how much you're getting from your doses if you're on a low-salt diet. If you experience unexplained fainting, chest pain with physical activity, or irregular heartbeat while taking Aleve-D (naproxen / pseudoephedrine), contact your provider.
Kidney damage
Risk factors: Older adult | Kidney problems | Heart failure | Liver problems | High blood sugar | Sepsis | Having high amounts of certain proteins in blood (paraproteinemia) | Not enough fluids in the body (dehydration) | Taking other medications that can cause kidney problems
Naproxen in Aleve-D (naproxen / pseudoephedrine) can cause kidney problems. Your risk is higher if you have certain factors like older age, certain medical problems like diabetes, or you're taking medications that can cause kidney problems. Your provider may order lab tests to monitor your kidney health before and during treatment with Aleve-D (naproxen / pseudoephedrine). If your kidney health worsens, your provider might stop your Aleve-D (naproxen / pseudoephedrine) treatment. Contact your provider if you develop any signs or symptoms of kidney failure, including changes in your need to urinate, tiredness, dry and itchy skin, low appetite, and muscle cramps.
Harm to unborn babies
Risk factor: Currently in second or third trimester of pregnancy
Don't use Aleve-D (naproxen / pseudoephedrine), specifically naproxen, starting at 20 weeks of pregnancy. It can cause serious complications, such as heart or kidney problems in your unborn baby. If you're pregnant, speak to your provider about the risks and benefits of Aleve-D (naproxen / pseudoephedrine) and ask if there are safer alternatives.
Risk of medication interactions
Aleve-D (naproxen / pseudoephedrine) can interact with some medications. For example, you can't take Aleve-D (naproxen / pseudoephedrine) within 2 weeks of taking a monoamine oxidase inhibitor (MAOI). MAOIs can interact with pseudoephedrine and cause dangerously high blood pressure. Another example is that you can't take Aleve-D (naproxen / pseudoephedrine) if you're taking other NSAIDS because doing so raises your risk for stomach ulcers. Before starting Aleve-D (naproxen / pseudoephedrine), ask your provider or pharmacist to help you check for medication interactions.
Accidentally taking too much medication (overdose)
Risk factor: Taking with other similar medications
Aleve-D (naproxen / pseudoephedrine) contains a decongestant (pseudoephedrine) and a painkiller (naproxen), which are found in many other over-the-counter products. Using more than one product containing the same ingredients can lead to an accidental overdose that can be dangerous. For example, taking too much pseudoephedrine can cause serious side effects, such as headache, dizziness, anxiety, ringing in the ears, blurry vision, chest pain, fast heart rate, changes in blood pressure, nausea, and vomiting. Taking too much naproxen can cause serious stomach bleeding and ulcers.
If you're not sure whether you're taking a medication with any of the ingredients in Aleve-D (naproxen / pseudoephedrine), talk to your provider or pharmacist. To prevent an accidental overdose, follow the specific product instructions on the package carefully. If you think that you or your child might’ve accidentally taken too much Aleve-D (naproxen / pseudoephedrine), call a Poison Center at 1-800-222-1222 right away even if you aren't completely sure.
Aleve-D (naproxen / pseudoephedrine) dosage forms
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 220mg/120mg | 20 tablets | $10.85 | $0.54 |
Typical dosing for Aleve-D (naproxen / pseudoephedrine)
Each tablet contains 220 mg of naproxen and 120 mg of pseudoephedrine.
Adults and children 12 years and older: The typical dose is 1 tablet by mouth every 12 hours. Don't take more than 2 tablets in a 24-hour period.
Children under 12 years old: Don't use.
How much does Aleve-D (naproxen / pseudoephedrine) cost?
Aleve-D (naproxen / pseudoephedrine) contraindications
What are alternatives to Aleve-D (naproxen / pseudoephedrine)?
Short-term relief of symptoms due to the common cold or flu:
Sinus congestion and pressure
Headache
Body aches and pains
Fever
Short-term relief of symptoms from the common cold or flu: headache, fever, sinus pressure, nasal congestion, minor body aches and pains
Lowers swelling in nasal passages
Improves freer breathing through the nose
Headache
Fever
Sinus pressure
Stuffy nose
Minor body aches and pains
What is the latest news about Aleve-D (naproxen / pseudoephedrine)?
Aleve-D (naproxen / pseudoephedrine) images
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References
Best studies we foundBayer HealthCare LLC. (2023). Aleve-D Sinus and Cold- naproxen sodium, pseudeoephedrine hydrochloride tablet [package insert]. DailyMed.
Centers for Disease Control and Prevention. (2024). Medication safety and your health.
Ellison, J., et al. (2007). Recent FDA warning of the concomitant use of aspirin and ibuprofen and the effects on platelet aggregation. Preventive Cardiology.
Głowacka, K., et al. (2021). Pseudoephedrine-Benefits and risks. International Journal of Molecular Sciences.
Johnson & Johnson Consumer Inc. (2024). Sudafed Sinus 12 Hour Pressure Plus Pain- naproxen sodium and pseudoephedrine hydrochloride tablet, multilayer, extended release [package insert]. DailyMed.
National Kidney Foundation. (2020). 10 signs you may have kidney disease.
U.S. Food and Drug Administration. (2017). Legal requirements for the sale and purchase of drug products containing pseudoephedrine, ephedrine, and phenylpropanolamine.
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