Tylenol Dual Action Acetaminophen + Ibuprofen: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• If you have, or previously had, any of the following medical conditions, ask your doctor before taking TYLENOL^® Dual Action Acetaminophen + Ibuprofen:

  • Heart Failure
  • High blood pressure
  • Kidney or liver disease

  • Pregnant or nursing.

• TYLENOL^® Dual Action Acetaminophen + Ibuprofen should not be used during third trimester of pregnancy; use during the first and second trimesters of pregnancy or nursing should be avoided.

• Stomach bleeding warning: This product 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 aged 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinner 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.

• Liver warning: TYLENOL^® Dual Action Acetaminophen + Ibuprofen contains acetaminophen, which has been associated with cases of acute liver failure. Severe or possibly fatal liver damage may occur if you take:

  • more than 6 tablets within 24 hours which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • while drinking three (3) or more alcoholic drinks every day.

Symptoms of liver damage may include yellow skin/eyes, dark urine, sweating, nausea, vomiting, stomach pain, unusual tiredness, and/or loss of appetite.

• Stop use and contact a doctor if you observe blood in the urine or you develop urgent, frequent, painful or difficult urination.
• Use with caution in the elderly or those taking diuretics.
• Allergy alert: This product may cause serious skin reactions and severe allergic reaction, especially in people allergic to ASA. Symptoms may include skin reddening, skin blisters, rash, hives, severe itching, swelling of eyes and mouth, and difficulty breathing. If any of the above noted symptoms occur, stop use and seek medical help right away.

What is TYLENOL^® Dual Action Acetaminophen + Ibuprofen used for?

For fast and effective temporary relief of muscle aches and pain, joint and body pain, backache, muscle sprains and strains, pain of inflammation associated with conditions including arthritis and physical or athletic overexertion (e.g. sprains or strains), headache including tension headache, migraine pain, dental pain, pre-menstrual & menstrual pain, aches and pain due to the common cold and for reduction of fever.

How does TYLENOL^® Dual Action Acetaminophen + Ibuprofen work?

TYLENOL^® Dual Action Acetaminophen + Ibuprofen works via a dual action mechanism. Ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), fights pain at its source and reduces fever. Acetaminophen blocks the transmission of pain signals to your brain. It also acts in the brain to reduce fever.

What are the ingredients in TYLENOL^® Dual Action Acetaminophen + Ibuprofen?

Medicinal ingredients: Ibuprofen and acetaminophen.

Non-medicinal ingredients: Colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, ferric oxide, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide.

TYLENOL^® Dual Action Acetaminophen + Ibuprofen comes in the following dosage forms:

Ibuprofen 125 mg/Acetaminophen 250 mg tablets.

Do not use TYLENOL^® Dual Action Acetaminophen + Ibuprofen if:

you have or are

• active or recurrent stomach ulcer, gastrointestinal (GI) bleeding, or active inflammatory bowel

  disease (e.g. Crohn’s, colitis)

• taking any other drug containing acetaminophen (can cause severe or possibly fatal liver damage; if you are not sure if a drug contains acetaminophen ask a doctor or pharmacist), acetylsalicylic acid (ASA) or any other NSAIDs including any other ibuprofen product
• allergic/hypersensitive to acetaminophen, ASA, ibuprofen, other salicylates, other NSAIDs or any of TYLENOL^® Dual Action Acetaminophen + Ibuprofen ingredients (Refer to the nonmedicinal ingredients on the outer carton or composition section)
• nasal polyps (swelling of the inside of the nose), or allergic manifestations such as asthma, anaphylaxis (sudden severe life threatening allergic reaction), urticaria/hives, rhinitis (stuffed or runny nose that may be due to allergies), skin rash or other allergic symptoms
• dehydrated (significant fluid loss) due to vomiting, diarrhea or lack of fluid intake
• diagnosed with severe high blood pressure or have severe coronary artery disease
• planning to have or have recently had heart surgery
• serious liver or kidney disease
• Systemic Lupus Erythematosus
• high potassium in the blood
• in your third trimester of pregnancy.

TYLENOL^® Dual Action Acetaminophen + Ibuprofen should NOT be used in patients under 18 years of age since the safety and effectiveness have NOT been established.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TYLENOL^® Dual Action Acetaminophen + Ibuprofen. Talk about any health conditions or problems you may have, including if you:

• have liver or kidney disease, swelling of ankles or feet, ulcers or stomach bleeding history, high blood pressure, heart disease, diabetes, any other serious condition
• take the blood thinning drug warfarin, take any other medication especially low-dose ASA (81 to 325 mg) or take any other drugs including over the counter drugs
• trying to conceive, or in your first or second trimester of pregnancy, or breastfeeding
• plan to have a surgery
• have asthma, glaucoma, blood clotting disorder (such as hemophilia), an infection, indigestion and heartburn, inflammation of intestine or any other stomach problems, diarrhea, vomiting blood or bleeding from back passage
• consume excessive alcohol.

Other warnings you should know about:

When using this product

• take with food or milk if upset stomach occurs

• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.

Stop use and ask a doctor if:

• you have signs of stomach bleeding (see Serious Warnings and Precautions – Stomach bleeding warning)
• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
• any new symptoms appear.

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 TYLENOL^® Dual Action Acetaminophen + Ibuprofen (NOT a complete list):

• medicine that affects or toxic to liver (including alcohol) (e.g. antibiotics, Atorvastatin)
• medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin) may increase the risk of ulceration and bleeding
• acetylsalicylic acid (ASA) or other NSAIDs. Ibuprofen may interfere with the preventive benefits of ASA
• medicines that reduce high blood pressure (ACE-inhibitors, beta-blockers, angiotensin-II receptor antagonists)
• digoxin to treat abnormal heart rhythm
• diuretics, also called water pills used to increase urine output
• serotonin reuptake inhibitors (SSRIs) used to treat depression
• corticosteroids, such as prednisone, cortisone
• methotrexate, a medicine used to treat arthritis and some types of cancer
• lithium, a medicine used to treat some types of depression
• benzodiazepines a medicine used to treat some types of depression
• protein-bound drugs including probenecid
• oral antidiabetic agents and insulin.

How to take TYLENOL^® Dual Action Acetaminophen + Ibuprofen:

Take the lowest dose of this medication for the shortest time period. Taking too much TYLENOL^® Dual Action Acetaminophen + Ibuprofen may increase your chances of unwanted and sometimes dangerous side effects, especially if you are elderly, have other diseases or take other medications.

Usual dose:

Adults 18 years and over: Take 2 tablets every 8 hours while symptoms persist. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Do not take more than directed (see liver warning). Do not use longer than 3 days for a fever or 5 days for pain relief.

TYLENOL^® Dual Action Acetaminophen + Ibuprofen provides up to 8 hours of pain relief.

Overdose:

Missed Dose:

If you miss a dose, take it as soon as you remember. But if it is almost time for the next dose, do not take the missed dose. Instead, take the next scheduled dose. Do not try to make up for the missed dose by taking a double dose next time.

What are possible side effects from using TYLENOL^® Dual Action Acetaminophen + Ibuprofen?

These are not all the possible side effects you may feel when taking TYLENOL^® Dual Action Acetaminophen + Ibuprofen. If you experience any side effects not listed here, contact your healthcare professional.

Possible serious side effects are summarized below from data available for the individual drugs, ibuprofen and acetaminophen.

Call a Poison Control Centre or a healthcare professional immediately, even if you do not notice any signs or symptoms. Early symptoms of liver damage may seem like the flu, or you may have nausea, vomiting, stomach pain, loss of appetite, yellowing of the skin/eyes, or dark urine.

Serious side effects and what to do about them

Other self-limiting side effects that may occur include heartburn, nausea or vomiting, bloating, diarrhea or constipation, nervousness, sleeplessness or itching. 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.

Storage:

Store at room temperature (15°-30°C).

Keep out of reach of children. This package contains enough medicine to seriously harm a child.

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.

If you want more information about TYLENOL^® Dual Action Acetaminophen + Ibuprofen:

• Talk to your healthcare professional
• This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Kenvue Canada Inc., at: 1-800-265-7323