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Ibuprofen Plus Acetaminophen: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Over-the-counter (OTC)
Strength:
125 mg / 250 mg
Active ingredients:

Patient Medication Information: uses, side effects, how to take - Ibuprofen Plus Acetaminophen

Serious Warnings and Precautions

  • If you have, or previously had, any of the following medical conditions, ask your doctor before taking Ibuprofen Plus Acetaminophen:

    • Heart Failure
    • High blood pressure
    • Kidney or liver disease
    • Pregnant or nursing.

  • Ibuprofen Plus Acetaminophen should not be used during third trimester of pregnancy.
  • Talk to your doctor if you are trying to conceive, in your first or second trimester of pregnancy or if breastfeeding.
  • 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: Ibuprofen Plus Acetaminophen 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 Ibuprofen Plus Acetaminophen 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 Ibuprofen Plus Acetaminophen work?

Ibuprofen Plus Acetaminophen 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 Ibuprofen Plus Acetaminophen?

Medicinal ingredients: Ibuprofen and acetaminophen.

Non-medicinal ingredients: Colloidal Silicon Dioxide, Croscarmellose Sodium, Glyceryl Dibehenate, Hypromellose, Iron Oxide Black, Iron Oxide Yellow, Lactose Monohydrate, Polyethylene Glycol 3350, Povidone, Pregelatinized Starch, Titanium Dioxide.

Ibuprofen Plus Acetaminophen comes in the following dosage forms:

Tablets; Ibuprofen 125 mg and Acetaminophen 250 mg.

Do not use Ibuprofen Plus Acetaminophen 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 Ibuprofen Plus Acetaminophen 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.

Ibuprofen Plus Acetaminophen 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 Ibuprofen Plus Acetaminophen. 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, pregnant 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:

  • The use of NSAIDs, like Ibuprofen Plus Acetaminophen, in the second trimester of pregnancy should be restricted to the lowest dose necessary for the shortest possible duration.
  • At 20 weeks or later in pregnancy, your use of NSAIDs may need to be monitored by a doctor due to the rare risk of kidney problems in the unborn baby which may result in decreased amniotic fluid volume and other complications.

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 Ibuprofen Plus Acetaminophen (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 Ibuprofen Plus Acetaminophen:

Take the lowest dose of this medication for the shortest time period. Taking too much Ibuprofen Plus Acetaminophen 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.

Ibuprofen Plus Acetaminophen provides up to 8 hours of pain relief.

Overdose:

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.

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 Ibuprofen Plus Acetaminophen?

These are not all the possible side effects you may feel when taking Ibuprofen Plus Acetaminophen. 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.

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 severeIn all cases
COMMON
Dizziness
UNCOMMON
Abdominal pain
Bloody or black stools
Skin rashes, skin reddening
Ringing or buzzing in the ears
RARE
Vomiting blood or dark coloured vomit
Shortness of breath, wheezing
Fluid retention (e.g. swelling in the hands or feet)
VERY RARE
Severe allergic reactions (trouble breathing or chest tightness, hives, swelling or itching)
Serious skin reactions (blisters, reddening, peeling)
Jaundice (yellowing of the eyes or skin due to liver problems)
Low blood platelet count

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.

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 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 room temperature (15°-30°C).

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

If you want more information about Ibuprofen Plus Acetaminophen:

  • 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 Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling 1-866-840-1340.

Date of Authorization: 2026-09-11

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02571420

Approved according to the text: September 11, 2026

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 Ibuprofen Plus Acetaminophen

Rx or OTC
Over-the-counter (OTC)?
DIN 02571420
Schedule(s) NON-PRESCRIPTION DRUGS
Active ingredient(s) Ibuprofen 125 MG, Acetaminophen 250 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 SUN PHARMA CANADA INC
Current status Approved
Current status date September 11, 2026

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.