Patient Medication Information: uses, side effects, how to take - Pain Reliever & Sleep Aid
What is Pain Reliever & Sleep Aid used for?
- Trust Pain Reliever & Sleep Aid for providing fast and effective relief of occasional, night time, minor pain and accompanying sleeplessness due to aches and pain associated with joints, muscles, backache, headaches, toothaches, as well as pain of migraine, dental extractions, inflammation and arthritis.
- Helps you to fall asleep and stay asleep.
- For use only if you have short-term night time sleeplessness caused by pain. If this is not the case, do not use.
How does Pain Reliever & Sleep Aid work?
Pain Reliever & Sleep Aid is a pain reliever and sleep-aid. The pain relief from naproxen sodium helps to fall asleep and diphenhydramine hydrochloride helps to stay asleep.
What are the ingredients in Pain Reliever & Sleep Aid?
Medicinal ingredients: Naproxen sodium, Diphenhydramine hydrochloride
Non-medicinal ingredients: Hypromellose, indigotine Al Lake 12-14% (Blue #2), magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, silicon dioxide, stearic acid and titanium dioxide.
Pain Reliever & Sleep Aid comes in the following dosage forms:
Caplet: naproxen sodium 220 mg / diphenhydramine hydrochloride 25 mg.
Do not use Pain Reliever & Sleep Aid if:
You have or are:
- pain that does not keep you from sleeping
- sleeplessness but are not in pain
- allergic to naproxen, naproxen sodium, diphenhydramine hydrochloride or any ingredient in the product
- allergic to acetylsalicylic acid (ASA), other salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs)
- an active peptic ulcer, a history of recurrent ulceration, or active gastrointestinal bleeding
- inflammatory bowel disease
- liver disease (active or severe)
- kidney disease (severe or worsening)
- right before or after heart surgery
in your third trimester of pregnancy because it may cause problems in the unborn child or complications during delivery
- do not have time for a full night’s sleep
- elderly, as this drug may cause excitation rather than sedation
- taking with any other product containing diphenhydramine, even one used on skin
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Pain Reliever & Sleep Aid. Talk about any health conditions or problems you may have, including if you:
Have or have had:
- asthma or a similar respiratory illness
- diabetes
- nasal polyps
- itchy skin and hives
- history of gastrointestinal disease
- high blood pressure
- a blood clotting disorder
- heart disease/failure
- difficulty urinating due to enlarged prostate gland
- glaucoma
- any other serious condition
- sleeplessness due to mild to moderate pain persists continually for more than 5 days
Are:
- trying to conceive
- in your first or second trimester of pregnancy
- breastfeeding
- older than age 65
- taking sedatives or tranquilizers
- taking any other drug
Sleeplessness may be a symptom of a serious underlying medical condition other than pain.
Other warnings you should know about:
Stomach bleeding warning: This may cause stomach bleeding.
Symptoms may include:
- feeling faint, vomiting blood, bloody or black stools.
The chance of stomach bleeding is higher if you:
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take with other drugs containing an NSAID like acetylsalicylic acid (ASA), ibuprofen, naproxen, or prescription anti-inflammatory drugs
- have 3 or more alcoholic drinks every day while using this product.
Allergy alert: Stop use and get medical help right away if you have ▪hives ▪swelling of eyes and mouth ▪wheezing ▪shock ▪skin reddening ▪blisters ▪rash
When using this product:
- risk of heart attack or stroke may increase if you use more than directed or for longer than directed
- avoid drinking alcohol
Stop use and ask a doctor if:
- fever lasts more than 3 days
- pain and sleeplessness lasts more than 5 days or if your symptoms change
- symptoms get worse or new ones appear
Driving and using machines: If you become drowsy, dizzy or lightheaded do not drive or operate machinery and contact your doctor or pharmacist.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Pain Reliever & Sleep Aid:
- Anticoagulants (to decrease blood clotting)
- Antihistamines, tranquilizers, alcohol or other sedating drugs
- Antihypertensive drugs for your heart (including ACE inhibitors and beta-blockers)
- Cyclosporine
- Diuretics (“water pills”)
- Glucocorticoids
- Lithium
- Low dose ASA for doctor supervised daily preventative therapy (e.g. ASPIRIN* 81 mg)
- Methotrexate
- NSAIDs or other pain medications (e.g. ibuprofen, acetaminophen)
Do not use this product if you are taking acetylsalicylic acid (ASA) for preventive therapy without talking to a doctor or pharmacist. Naproxen sodium may interfere with the preventive benefits of ASA.
Taking Pain Reliever & Sleep Aid with a meal may slightly delay its absorption.
How to take Pain Reliever & Sleep Aid:
Drink a full glass of water with each dose. Do not use in children under 12 years.
Usual dose:
Adults and children ≥ 12 years: 2 tablets at bedtime. Do not take more than 2 tablets in a 24 hour period.
Overdose:
If you think you, or a person you are caring for, have taken too much Pain Reliever & Sleep Aid, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
Take once at night before bedtime. If you miss one night’s dose, do not take twice the recommended dose on the next night.
What are possible side effects from using Pain Reliever & Sleep Aid?
These are not all the possible side effects you may have when taking Pain Reliever & Sleep Aid. If you experience any side effects not listed here, tell your healthcare professional. Like all medicines, Pain Reliever & Sleep Aid may occasionally produce unwanted side effects. Stop use and contact a doctor or pharmacist if you experience: heartburn, nausea, vomiting, ringing or buzzing in the ears, bloating, redness or swelling is present in the painful area, choking sensation, diarrhea or constipation.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| COMMON | |||
| Abdominal pain | √ | ||
| UNCOMMON | |||
| Black stools | √ | ||
| Hives | √ | ||
| Itching | √ | ||
| Rash | √ | ||
| Skin reddening | √ | ||
| Feel faint | √ | ||
| RARE | |||
| Facial Swelling | √ | ||
| Fluid retention | √ | ||
| Vomiting blood | √ | ||
| VERY RARE | |||
| Change in vision | √ | ||
| Difficulty Breathing | √ | ||
| Shock | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional. Drowsiness is an expected effect of this medicine.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store at 20 to 25°C (68 to 77°F). Avoid exposure to high humidity and excessive heat above 40°C (104°F).
- CAUTION: Contains enough drug to seriously harm a child. KEEP OUT OF REACH AND SIGHT OF CHILDREN.
If you want more information about Pain Reliever & Sleep Aid:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.
Date of Authorization: 2025-08-14
*Brands listed are trademarks of their respective owners.