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Naproxen/ diphenhydramine

Generic Name: naproxen/diphenhydramine (na-PROX-en/DYE-fen-HYE-dra-meen)
Brand Name: Aleve PM

Naproxen/diphenhydramine contains a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke). The risk may be greater if you already have heart problems or if you take naproxen/diphenhydramine for a long time. Do not use naproxen/diphenhydramine right before or after bypass heart surgery.

Naproxen/diphenhydramine may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.


Naproxen/ diphenhydramine is used for:

Relieving occasional sleeplessness due to minor aches and pain.

Naproxen/diphenhydramine is an antihistamine and NSAID combination. Diphenhydramine causes drowsiness to help you fall asleep. The NSAID may block certain substances in the body that are linked to inflammation and relieve the symptoms of pain and inflammation.

Do NOT use naproxen/ diphenhydramine if:

  • you are allergic to any ingredient in naproxen/diphenhydramine
  • you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or another NSAID (eg, ibuprofen, celecoxib)
  • you have recently had or will be having bypass heart surgery
  • you have severe kidney problems
  • you are in the last 3 months of pregnancy
  • you are not able to get a full night's sleep
  • you are not able to sleep because of reasons other than aches and pains
  • you are taking any other NSAID

Contact your doctor or health care provider right away if any of these apply to you.

Before using naproxen/ diphenhydramine:

Some medical conditions may interact with naproxen/diphenhydramine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of kidney or liver problems, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers, heartburn, ulcerative colitis, Crohn disease)
  • if you have a history of swelling or fluid buildup, asthma or other breathing problems (eg, emphysema, bronchitis), growths in the nose (nasal polyps), or mouth inflammation
  • if you have high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure), or a blood vessel disease, or if you are at risk of any of these diseases
  • if you have glaucoma, an enlarged prostate, trouble urinating, poor health, dehydration or low fluid volume, low blood sodium levels, or are on a low-salt (sodium) diet
  • if you drink alcohol, smoke, or have a history of alcohol abuse

Some MEDICINES MAY INTERACT with naproxen/diphenhydramine. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticoagulants (eg, warfarin), antiplatelet medicines (eg, clopidogrel, prasugrel), aspirin, corticosteroids (eg, prednisone), heparin, rivaroxaban, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or other NSAIDs (eg, ibuprofen) because the risk of stomach bleeding may be increased
  • Probenecid because it may increase the risk of naproxen/diphenhydramine's side effects
  • Bisphosphonates (eg, alendronate), cyclosporine, hydantoins (eg, phenytoin), lithium, methotrexate, quinolones (eg, ciprofloxacin), sulfonamides (eg, sulfamethoxazole), or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by naproxen/diphenhydramine
  • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), beta-blockers (eg, propranolol), or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by naproxen/diphenhydramine

This may not be a complete list of all interactions that may occur. Ask your health care provider if naproxen/diphenhydramine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use naproxen/ diphenhydramine:

Use naproxen/diphenhydramine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take naproxen/diphenhydramine by mouth with or without food. If stomach upset occurs, take with food or milk to reduce stomach irritation. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
  • Take naproxen/diphenhydramine with a full glass of water (8 oz [240 mL]) as directed by your doctor.
  • If you take antacids, cholestyramine, or sucralfate, ask your doctor or pharmacist how to take them with naproxen/diphenhydramine.
  • If you miss a dose of naproxen/diphenhydramine and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use naproxen/diphenhydramine.

Important safety information:

  • Naproxen/diphenhydramine may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use naproxen/diphenhydramine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol while you are taking naproxen/diphenhydramine.
  • Check with your doctor before you use medicine that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using naproxen/diphenhydramine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Serious stomach ulcers or bleeding can occur with the use of naproxen/diphenhydramine. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking naproxen/diphenhydramine with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
  • Talk to your doctor before you take naproxen/diphenhydramine if you drink more than 3 drinks with alcohol per day.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and can sometimes cause death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • If you have pain that does not get better within 10 days or sleeplessness that lasts for more than 2 weeks, check with your doctor. If your symptoms get worse or if you have new symptoms, check with your doctor.
  • Do NOT take more than the recommended dose or use for longer than directed without checking with your doctor.
  • Contact your doctor if you have trouble swallowing, severe or persistent heartburn, or if it feels like the tablet is stuck in your throat.
  • Tell your doctor or dentist that you take naproxen/diphenhydramine before you receive any medical or dental care, emergency care, or surgery.
  • Naproxen/diphenhydramine has naproxen in it. Before you start any new medicine, check the label to see if it has naproxen or any other NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • Do not take aspirin while you are using naproxen/diphenhydramine unless your doctor tells you to.
  • Do not use with other products that contain diphenhydramine, even products used on the skin.
  • Naproxen/diphenhydramine may interfere with certain lab tests. Be sure your doctor and lab personnel know that you take naproxen/diphenhydramine.
  • Use naproxen/diphenhydramine with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.
  • Naproxen/diphenhydramine should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Naproxen/diphenhydramine may cause harm to the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using naproxen/diphenhydramine while you are pregnant. Naproxen/diphenhydramine should not be used during labor. Naproxen/diphenhydramine is found in breast milk. If you are or will be breast-feeding while you use naproxen/diphenhydramine, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of naproxen/ diphenhydramine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; gas; heartburn; nausea; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; loss of appetite; mental or mood changes; numbness of an arm or leg; one-sided weakness; pale stools; ringing in the ears or hearing changes; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of the hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of naproxen/diphenhydramine:

Store naproxen/diphenhydramine at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Avoid temperatures above 104 degrees F (40 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep naproxen/diphenhydramine out of the reach of children and away from pets.

General information:

  • If you have any questions about naproxen/diphenhydramine, please talk with your doctor, pharmacist, or other health care provider.
  • Naproxen/diphenhydramine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take naproxen/diphenhydramine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about naproxen/diphenhydramine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to naproxen/diphenhydramine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using naproxen/diphenhydramine.

Review Date: August 8, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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