Patient Medication Information: uses, side effects, how to take - Extra Strength Tylenol Nighttime
What is EXTRA STRENGTH TYLENOL® NIGHTTIME used for?
- Extra Strength TYLENOL® Nighttime 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.
How does EXTRA STRENGTH TYLENOL® NIGHTTIME work?
Extra Strength TYLENOL® Nighttime 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.
What are the ingredients in EXTRA STRENGTH TYLENOL® NIGHTTIME?
Medicinal ingredients: Acetaminophen 500 mg, Diphenhydramine Hydrochloride 25 mg
Non-medicinal ingredients: Carnauba wax, cellulose, corn starch, FD&C blue no.1 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, sodium citrate, sodium starch glycolate, titanium dioxide.
EXTRA STRENGTH TYLENOL® NIGHTTIME comes in the following dosage forms:
EXTRA STRENGTH TYLENOL® NIGHTTIME caplets are a combination of 500 mg of acetaminophen (extra strength) and 25 mg of diphenhydramine hydrochloride, which is available as light blue coloured caplets.
Do not use EXTRA STRENGTH TYLENOL® NIGHTTIME if:
Serious Warnings and Precautions
- Causes sedation or sleepiness. Not for daytime use.
- Do not take more than the maximum daily dose. Overdose my result in severe or possibly fatal liver damage.
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- You are taking any other drug containing acetaminophen or diphenhydramine, even one used on the skin
- You have pain that does not keep you from sleeping
- You have sleeplessness but are not in pain
- You are allergic to acetaminophen, diphenhydramine hydrochloride or any of the other ingredients in this product. If you are not sure whether a drug contains acetaminophen or diphenhydramine, ask a doctor or pharmacist
In children under 16 years of age.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take EXTRA STRENGTH TYLENOL® NIGHTTIME Talk about any health conditions or problems you may have, including if you:
- Have serious kidney or liver disease
- Have chronic lung disease (including acute or chronic bronchial asthma, emphysema or chronic bronchitis), glaucoma, or difficulty in urination due to enlargement of the prostate gland
Are pregnant or breastfeeding
- Are elderly and experience confusion at night, as this drug may cause excitation rather than sedation
- Use any other medications including the blood thinning drug warfarin, sedatives or tranquilizers or other pain and fever relief medications
- Have peptic ulcer
Other warnings you should know about:
KEEP OUT OF THE REACH OF CHILDREN. This package contains enough drug to seriously harm a child. Use only on the advice of a doctor.
Liver warning: Acetaminophen may cause severe or possibly fatal liver damage if you take:
- more than the recommended dose in 24 hours;
- with other drugs containing acetaminophen;
while drinking 3 or more alcoholic drinks every day.
Symptoms of liver damage may include:
- yellow skin or eyes, dark urine;
- sweating, nausea, vomiting, stomach pain;
- unusual tiredness, and/or loss of appetite.
Allergy alert: acetaminophen may cause serious skin reactions. Symptoms may include:
- skin reddening, blisters, rash
If any of these symptoms occur, stop use and seek medical help right away.
May cause marked drowsiness or excitability. Alcohol, sedatives and tranquilizers may increase drowsiness. Do not drive a motor vehicle, operate machinery or engage in activities requiring alertness when using this product. Avoid alcohol.
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Stop use and ask a doctor if sleeplessness due to mild to moderate pain lasts for more than 5 days, if new symptoms appear or existing symptoms worsen. Sleeplessness may be a symptom of serious underlying medical illness.
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 EXTRA STRENGTH TYLENOL® NIGHTTIME:
- 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
How to take EXTRA STRENGTH TYLENOL® NIGHTTIME:
Usual dose:
Adult use only (16 years and older): Take 2 Extra Strength TYLENOL® Nighttime caplets at bedtime, or as directed by a doctor. Do not take more than 2 caplets in 24 hours.
Overdose:
If you think you, or a person you are caring for, have taken too much EXTRA STRENGTH TYLENOL® NIGHTTIME, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
Take once at night before bedtime. Do not take twice the recommended dose after a missed dose.
What are possible side effects from using EXTRA STRENGTH TYLENOL® NIGHTTIME?
These are not all the possible side effects you may have when taking EXTRA STRENGTH TYLENOL® NIGHTTIME. If you experience any side effects not listed here, tell your healthcare professional.
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.
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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 | ||
| VERY RARE | |||
| Allergic reactions such as itching, blisters, rashes, skin reddening etc. | ✓ | ||
| Any change in vision, hallucinations, or difficulty speaking | ✓ | ||
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.
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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store caplets at 15 to 30◦C.
Keep out of reach and sight of children.
If you want more information about EXTRA STRENGTH TYLENOL® NIGHTTIME:
- 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; the manufacturer’s website www.tylenol.ca, or by calling 1-800-265-7323.
Date of Authorization: February 26, 2026