Drug-labels.com

Extra Strength Nighttime Pain Reliever / Sleep Aid: Uses, Side Effects and Dosage

Status:
Over-the-counter (OTC) Current status: Cancelled Pre Market Facts
Strength:
500 mg / 25 mg
Active ingredients:
ATC code:
Similar drugs:

Source: Health Canada – Drug Product Database (DPD) and product monographs · About this document

Patient Medication Information: uses, side effects, how to take - Extra Strength Nighttime Pain Reliever / Sleep Aid

ABOUT THIS MEDICATION

What the medication is used for:

  • Extra Strength Nighttime Pain Reliever / Sleep Aid provides fast and effective relief of occasional mild to moderate nighttime pain and accompanying sleeplessness due to back and body pain, headaches, muscle aches and pains, arthritis pain, menstrual pain, dental pain and aches and pains due to colds and the flu.
  • Helps improve the duration of your sleep.

What it does:

Extra Strength Nighttime Pain Reliever / Sleep Aid contains two drugs:

acetaminophen (a pain reliever) and diphenhydramine hydrochloride (a sleep aid for sleeplessness). Pain relief from acetaminophen helps you fall asleep and diphenhydramine hydrochloride helps you stay asleep.

When it should not be used:

Extra Strength Nighttime Pain Reliever / Sleep Aid should not be used:

  • If you have pain that does not keep you from sleeping
  • If you have sleeplessness but are not in pain
  • If you are allergic to acetaminophen, diphenhydramine hydrochloride or any of the other ingredients in this product.

  • In children under 16 years of age.

  • With alcohol.

What the medicinal ingredients are:

Acetaminophen and diphenhydramine hydrochloride

What the nonmedicinal ingredients are:

povidone, cellulose microcrystalline, crospovidone, silica colloidal anhydrous, stearic acid, macrogol, methacrylic acid copolymer type C, polyvinyl alcohol, sodium bicarbonate, talc, titanium dioxide, FD&C blue #1 aluminum lake, FD&C yellow #5 aluminum lake

What dosage forms it comes in:

Extra Strength Nighttime Pain Reliever / Sleep Aid caplets are a combination of 500 mg of acetaminophen (extra strength) and 25 mg of diphenhydramine hydrochloride, which is available as blue colored caplets packaged in tamper-evident bottles of 30 caplets and blisters.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

  • Causes sedation or sleepiness. Not for daytime use.
  • Do not take more than the maximum daily dose. Overdose may result in severe or possibly fatal liver damage.

KEEP OUT OF THE REACH OF CHILDREN. This package contains enough drug to seriously harm a child. Do not use with other drugs containing acetaminophen or diphenhydramine, even one used on skin. Use only on the advice of a doctor.

BEFORE you use Extra Strength Nighttime Pain Reliever / Sleep Aid talk to your doctor or pharmacist if:

  • You have serious kidney or liver disease, or chronic alcoholism
  • You have chronic lung disease or respiratory condition (e.g. emphysema, chronic bronchitis, acute or chronic bronchial asthma), glaucoma, or difficulty in urination due to enlargement of the prostate gland

  • You are pregnant or breastfeeding

  • You are elderly and experience confusion at night
  • You use any other medications including natural health products, prescription drugs, salicylates or other pain and fever relief medications
  • You have peptic ulcer

Do not drive a motor vehicle, operate machinery, or engage in activities requiring alertness when using this product. If sleeplessness due to mild to moderate pain persists continuously for more than 5 days, consult your doctor. Insomnia may be a symptom of a serious underlying illness. If pain or fever persists or gets worse, or if new symptoms appear, consult a doctor. Consult a doctor if: you develop allergic wheezing or itching, your symptoms last for more than 5 days, or fever lasts more than 3 days. Very rarely, serious skin reactions with acetaminophen have been reported. Symptoms may include: skin reddening, blisters, rash. If a skin reaction occurs, stop use and seek medical help right away.

INTERACTIONS WITH THIS MEDICATION

As with most medications, interaction with other drugs is possible. Drugs that may interact with Extra Strength Nighttime Pain Reliever / Sleep Aid include:

  • Antihistamines, tranquilizers, alcohol or other sedating drugs
  • Medications for depression, including monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants and antipsychotics
  • Medications for blood pressure, including metoprolol and antiarrhythmic drugs
  • Opioid analgesic (e.g. tramadol)
  • Other pain relievers, sleep aids or cold medicines
  • Warfarin type anticoagulants and coumarin derivatives

PROPER USE OF THIS MEDICATION

Usual Dose:

Adult use only (16 years and older): Take 2 Extra Strength Nighttime Pain Reliever / Sleep Aid caplets, at bedtime or as directed by a doctor. Do not exceed 2 caplets per day.

Overdose:

In Case of Overdose: Call a Poison Control Centre or doctor immediately, even if you do not notice any possible signs or symptoms such as increased sweating, nausea, vomiting, stomach pain, and loss of appetite.

Missed Dose:

Take once at night before bedtime. Do not take twice the recommended dose after a missed dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

You may experience drowsiness, dizziness, dryness of mouth, nausea and nervousness. Other side effects may include rapid heartbeat, blurred vision, headache, restlessness or excitability, sensation of disorientation or motion, sleeplessness and production of thick mucus.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
STOP USE and consult a doctor immediately if you experience: an allergic reaction (itching, blisters, rashes, skin reddening, etc.), any change in vision, hallucinations, or difficulty speaking.

This is not a complete list of side effects. For any unexpected effects while taking Extra Strength Nighttime Pain Reliever / Sleep Aid, contact your doctor or pharmacist.

HOW TO STORE IT

Extra Strength Nighttime Pain Reliever / Sleep Aid caplets are to be stored between 15°C to 25°C.KEEP OUT OF REACH OF CHILDREN.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

--------------------------------------------------------------------------

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345

  • Complete a Canada Vigilance Reporting Form and:

    • Fax toll-free to 1-866-678-6789, or

    • Mail to: Canada Vigilance Program

      Health Canada

      Postal Locator 0701E

      Ottawa, Ontario

      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can found by contacting the sponsor, Teva Canada Limited by:

Phone: 1-800-268-4127 ext. 3

Email: druginfo@tevacanada.com; or

Fax: 1-416-335-4472.

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada M1B 2K9 www.tevacanada.com

Date Prepared: June 6, 2017

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02464632

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Extra Strength Nighttime Pain Reliever / Sleep Aid

Rx or OTC
Over-the-counter (OTC)?
DIN 02464632
Schedule(s) NON-PRESCRIPTION DRUGS
Active ingredient(s) Acetaminophen 500 MG, Diphenhydramine hydrochloride 25 MG
Dosage form(s) Tablet
Route(s) of administration Oral
Drug class (WHO ATC)
  1. N Nervous system drugs
    1. N02 Analgesics
      1. N02B Other analgesics and antipyretics
        1. N02BE Anilide analgesics and antipyretics
          1. N02BE51 Acetaminophen, comb excl psycholeptics
Company TEVA CANADA LIMITED
Current status Cancelled Pre Market
Current status date May 10, 2018

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.