Uses of Naproxen and Diphenhydramine:

• It is used to help you fall asleep and stay asleep when you are not able to sleep because of minor aches and pains.

What do I need to tell my doctor BEFORE I take Naproxen and Diphenhydramine?

For all patients taking naproxen and diphenhydramine:

• If you have an allergy to naproxen, diphenhydramine, or any other part of naproxen and diphenhydramine.
• If you have an allergy to aspirin or NSAIDs.
• If you are allergic to naproxen and diphenhydramine; any part of naproxen and diphenhydramine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have kidney disease.
• If you are pregnant or may be pregnant. Do not take naproxen and diphenhydramine if you are in the third trimester of pregnancy. You may also need to avoid naproxen and diphenhydramine at other times during pregnancy. Talk with your doctor to see when you need to avoid taking naproxen and diphenhydramine during pregnancy.
• If you do not have time to get a full night's sleep.
• If you are not able to sleep because of reasons other than minor aches and pains.
• If you are taking any of these drugs: Antacids, cholestyramine, cimetidine, famotidine, nizatidine, ranitidine, or sucralfate.
• If you are taking any other NSAID.

Children:

• If your child is younger than 12 years of age. Do not give naproxen and diphenhydramine to a child younger than 12 years of age.

This is not a list of all drugs or health problems that interact with naproxen and diphenhydramine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take naproxen and diphenhydramine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Naproxen and Diphenhydramine?

• Tell all of your health care providers that you take naproxen and diphenhydramine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for alertness while you take naproxen and diphenhydramine.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take naproxen and diphenhydramine.
• Avoid drinking alcohol while taking naproxen and diphenhydramine.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Do not use with other products that have diphenhydramine.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take naproxen and diphenhydramine for longer than you were told by your doctor.
• If you have asthma, talk with your doctor. You may be more sensitive to naproxen and diphenhydramine.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. Talk with the doctor.
• The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack. People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. Talk with the doctor.
• If you are taking aspirin to help prevent a heart attack, talk with your doctor.
• If you are 60 or older, use naproxen and diphenhydramine with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking naproxen and diphenhydramine, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Naproxen and Diphenhydramine) best taken?

Use naproxen and diphenhydramine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.
• Take with a full glass of water.
• If taken with food, naproxen and diphenhydramine may take longer to work.

What do I do if I miss a dose?

• If you take naproxen and diphenhydramine on a regular basis, take a missed dose as soon as you think about it.
• If you will not be able to get a full night's sleep (at least 7 hours) after taking the missed dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times naproxen and diphenhydramine is taken on an as needed basis. Do not take more often than told by the doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Chest pain or pressure or a fast heartbeat.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Very bad headache.
• Very bad dizziness or passing out.
• Feeling very tired or weak.
• Ringing in ears.
• Mood changes.
• Low mood (depression).
• Very upset stomach or throwing up.
• Very bad belly pain.
• Very bad back pain.
• Not able to pass urine or change in how much urine is passed.
• If it feels like the caplet is stuck in your throat.
• 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 sometimes 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.

What are some other side effects of Naproxen and Diphenhydramine?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Stomach pain or heartburn.
• Upset stomach or throwing up.
• Diarrhea.
• Constipation.
• Gas.
• Dizziness.
• Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Naproxen and Diphenhydramine?

• Store at room temperature.
• Protect from heat.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about naproxen and diphenhydramine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.