Diphenhydramine and naproxen (Oral route)

Pronunciation:

dye-fen-HYE-dra-meen hye-droe-KLOR-ide, na-PROX-en SOE-dee-um

Dosage Forms:

Tablet

Classifications:

Therapeutic—

Anti-Inflammatory

Pharmacologic—

Diphenhydramine

Chemical—

Diphenhydramine

Uses of This Medicine:

Diphenhydramine and naproxen combination is used to relieve trouble sleeping caused by minor aches and pains. It also helps you fall asleep and stay asleep.

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that is used in this combination to relieve inflammation, swelling, and pain.

This medicine is available as an over-the-counter (OTC) product.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of diphenhydramine and naproxen combination in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of diphenhydramine and naproxen combination in geriatric patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Calcium Oxybate
Ketorolac
Magnesium Oxybate
Potassium Citrate
Potassium Oxybate
Sodium Oxybate
Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abciximab
Aceclofenac
Acemetacin
Acenocoumarol
Alfentanil
Alprazolam
Amantadine
Amifampridine
Amiloride
Amineptine
Amitriptyline
Amitriptylinoxide
Amoxapine
Amtolmetin Guacil
Anagrelide
Apixaban
Ardeparin
Argatroban
Aspirin
Balsalazide
Bemetizide
Bemiparin
Bendroflumethiazide
Benzhydrocodone
Benzthiazide
Betamethasone
Betrixaban
Bismuth Subsalicylate
Bivalirudin
Bromazepam
Bromfenac
Bromopride
Budesonide
Bufexamac
Bumetanide
Buprenorphine
Bupropion
Butorphanol
Cangrelor
Cannabidiol
Cannabis
Carbinoxamine
Celecoxib
Ceritinib
Certoparin
Cetirizine
Chlorothiazide
Chlorthalidone
Choline Magnesium Trisalicylate
Choline Salicylate
Cilostazol
Citalopram
Clobazam
Clomipramine
Clonazepam
Clonixin
Clopamide
Clopidogrel
Clozapine
Codeine
Cortisone
Cyclopenthiazide
Cyclosporine
Cyclothiazide
Dabigatran Etexilate
Dalteparin
Danaparoid
Daridorexant
Deflazacort
Desipramine
Desirudin
Desmopressin
Desvenlafaxine
Dexamethasone
Dexibuprofen
Dexketoprofen
Dexmedetomidine
Diazoxide
Dibenzepin
Diclofenac
Diflunisal
Digoxin
Dihydrocodeine
Dipyridamole
Dipyrone
Donepezil
Dothiepin
Doxepin
Doxylamine
Droxicam
Duloxetine
Edoxaban
Emtricitabine
Enoxaparin
Eplerenone
Epoprostenol
Eptifibatide
Escitalopram
Esketamine
Ethacrynic Acid
Etodolac
Etofenamate
Etoricoxib
Etozolin
Felbinac
Fenoprofen
Fentanyl
Fepradinol
Feprazone
Feverfew
Flibanserin
Floctafenine
Fluconazole
Flufenamic Acid
Fluocortolone
Fluoxetine
Flurbiprofen
Fluvoxamine
Fondaparinux
Furosemide
Gabapentin
Gabapentin Enacarbil
Ginkgo
Glucagon
Glycopyrrolate
Glycopyrronium Tosylate
Gossypol
Heparin
Hydrochlorothiazide
Hydrocodone
Hydrocortisone
Hydroflumethiazide
Hydromorphone
Ibuprofen
Iloprost
Imipramine
Indapamide
Indomethacin
Inotersen
Ketamine
Ketoprofen
Lacosamide
Lemborexant
Lepirudin
Levocetirizine
Levomilnacipran
Levorphanol
Linezolid
Lithium
Lofepramine
Lofexidine
Lornoxicam
Loxapine
Loxoprofen
Lumiracoxib
Magnesium Salicylate
Meadowsweet
Meclizine
Meclofenamate
Mefenamic Acid
Melitracen
Meloxicam
Melphalan
Meperidine
Mesalamine
Methacholine
Methadone
Methotrexate
Methyclothiazide
Methylprednisolone
Metoclopramide
Metolazone
Midazolam
Milnacipran
Morniflumate
Morphine
Morphine Sulfate Liposome
Nabumetone
Nadroparin
Nalbuphine
Nefazodone
Nepafenac
Niflumic Acid
Nimesulide
Nimesulide Beta Cyclodextrin
Nortriptyline
Olanzapine
Olsalazine
Opipramol
Oxaprozin
Oxycodone
Oxymorphone
Oxyphenbutazone
Paramethasone
Parecoxib
Parnaparin
Paroxetine
Pemetrexed
Pentazocine
Pentosan Polysulfate Sodium
Pentoxifylline
Periciazine
Phenindione
Phenobarbital
Phenprocoumon
Phenylbutazone
Phenyl Salicylate
Piketoprofen
Piretanide
Piroxicam
Pitolisant
Pixantrone
Polythiazide
Potassium Citrate
Prasugrel
Prednisolone
Prednisone
Pregabalin
Primidone
Probenecid
Proglumetacin
Propyphenazone
Proquazone
Protein C
Protriptyline
Quetiapine
Quinethazone
Remifentanil
Remimazolam
Revefenacin
Reviparin
Rivaroxaban
Rofecoxib
Ropeginterferon Alfa-2b-njft
Salicylamide
Salicylic Acid
Salsalate
Scopolamine
Secretin Human
Selexipag
Sertraline
Sibutramine
Sodium Salicylate
Spironolactone
Sufentanil
Sulfasalazine
Sulfinpyrazone
Sulindac
Sulodexide
Tacrolimus
Tapentadol
Tenofovir Alafenamide
Tenofovir Disoproxil Fumarate
Tenoxicam
Tianeptine
Tiaprofenic Acid
Ticagrelor
Ticlopidine
Tinzaparin
Tiotropium
Tirofiban
Tolfenamic Acid
Tolmetin
Topiramate
Torsemide
Tramadol
Trazodone
Treprostinil
Triamterene
Trichlormethiazide
Trimipramine
Trolamine Salicylate
Valdecoxib
Venlafaxine
Vilazodone
Vorapaxar
Vortioxetine
Warfarin
Xipamide
Zolpidem
Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol
Atenolol
Azilsartan
Azilsartan Medoxomil
Benazepril
Betaxolol
Bisoprolol
Candesartan
Captopril
Carteolol
Carvedilol
Celiprolol
Enalapril
Enalaprilat
Eprosartan
Esmolol
Fosinopril
Irbesartan
Labetalol
Levobunolol
Lisinopril
Losartan
Metipranolol
Metoprolol
Moexipril
Nadolol
Nebivolol
Olmesartan
Oxprenolol
Penbutolol
Perindopril
Pindolol
Propranolol
Quinapril
Ramipril
Sotalol
Spirapril
Telmisartan
Timolol
Trandolapril
Valsartan

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Tobacco

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Allergy to aspirin or
Asthma or
Glaucoma or
Heart attack, history of or
Heart disease or
High blood pressure or
Kidney disease or
Liver disease (eg, cirrhosis) or
Lung or breathing problems (eg, emphysema, bronchitis) or
Stomach problems (eg, ulcers, bleeding, heartburn), history of or
Stroke, history of or
Trouble urinating caused by an enlarged prostate—Use with caution. May make these conditions worse.

Heart surgery—Should not be used to relieve pain right before or after the surgery.

Trouble sleeping without pain—Should not be used in patients with this condition.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not use this medicine if you have time for a full night's sleep.

Follow the instructions on the medicine label.

You may take this medicine with milk or food to avoid stomach upset. Drink a full glass of water after each dose.

Do not use this medicine if you are using other products (eg, skin products) that contain diphenhydramine.

Do not drink 3 or more alcoholic drinks while you are using this medicine. Drinking alcoholic beverages while taking this medicine may increase your risk of liver damage and stomach bleeding.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):
- For trouble sleeping caused by minor aches and pains, and to help you fall asleep and stay asleep:
  - Adults and children 12 years of age and older—2 tablets taken at bedtime. Each tablet contains 25 milligrams (mg) diphenhydramine and 220 mg naproxen. Do not take more than 2 tablets in 24 hours.
  - Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

If your or your child's symptoms do not improve (eg, pain for more than 10 days or trouble sleeping for more than 2 weeks), or if they become worse, check with your doctor.

Using this medicine during the later part of a pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may raise your risk of having a heart attack, heart failure, or stroke. This is more likely in people who already have heart disease or in people who use this medicine for a longer time.

This medicine may cause bleeding in your stomach. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (eg, steroid medicine, blood thinner).

This medicine may cause some people to become drowsy. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known: Bloody or black, tarry stools; chest pain, discomfort, or tightness; confusion; constipation; decreased urine output; diarrhea; difficulty in speaking; dilated neck veins; double vision; headache; heartburn; inability to move the arms, legs, or facial muscles; inability to speak; indigestion; irregular breathing; irregular heartbeat; nausea; pain or discomfort in the arms, jaw, back, or neck; severe stomach pain; slow speech; stomach cramping or burning; sweating; swelling of the face, fingers, feet, or lower legs; trouble breathing; vomiting; vomiting of blood or material that looks like coffee grounds; weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known: Difficulty swallowing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Last Updated: 11/16/2023

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