Advil Headache & Migraine Caplets: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Fast and effective relief of headache including tension headache, toothache, menstrual pain, minor aches and pain associated with muscles, bones and joints, sprains and strains, backache, body pain, pain from inflammation associated with arthritis or physical overexertion, and aches and pains due to the common cold and flu, in addition to reducing fevers.

Advil Headache & Migraine Caplets also provide temporary relief of mild to moderate migraine headaches including associated symptoms of nausea, and sensitivity to light and sound.

Provides up to 8 hours of long lasting pain relief.

What it does:

Ibuprofen sodium reduces pain and fever.

When it should not be used:

Do not use Advil Headache & Migraine Caplets if you have or are:

• allergic/hypersensitive to acetylsalicylic acid (ASA),

  ibuprofen, other salicylates, other non-steroidal anti-inflammatory drugs (NSAIDs) or any of Advil Headache & Migraine Caplet’s ingredients (Refer to the nonmedicinal ingredients section of this insert),

• peptic ulcer disease, gastrointestinal bleeding or active

  inflammatory bowel disease (e.g. Crohn’s, colitis) ,

• taking ASA or other NSAIDs including any other ibuprofen

  product,

• nasal polyps (swelling of the inside of the nose),
• asthma,

• allergic manifestations such as 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,

• been diagnosed with severe high blood pressure or have heart

  disease,

• about to have or just had heart surgery,
• serious liver disease,
• severe kidney disease,
• thyroid disease,
• Raynaud’s Syndrome (a disorder of the circulatory system),

• Systemic Lupus Erythematosus,

  • in your third trimester of pregnancy.

What the medicinal ingredient is:

Ibuprofen sodium dihydrate.

What the important nonmedicinal ingredients are:

acesulfame potassium, black iron oxide, caramel colour, carnauba wax, colloidal silicon dioxide, copovidone, hypromellose, mannitol, medium chain triglycerides, microcrystalline cellulose, natural and artificial flavours, polyethylene glycol, propylene glycol, red iron oxide, sodium lauryl sulfate, sucralose, titanium dioxide, yellow iron oxide.

What dosage forms it comes in:

Advil Headache & Migraine Caplets contain ibuprofen 200 mg, provided as 256 mg ibuprofen sodium dihydrate.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• Caution in patients with heart failure, high blood pressure or other conditions predisposing to fluid retention.

• Caution in patients at risk of gastrointestinal tract irritation, including those with a history of peptic ulcer. The chance of stomach bleeding is higher if you are: age 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.

• Caution in those at risk of kidney or liver problems, those taking diuretics and the elderly.
• Stop use immediately if you have difficulty or pain when urinating.
• Advil Headache & Migraine Caplets 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.

BEFORE you use Advil Headache & Migraine Caplets talk to your doctor or pharmacist if you have or are:

• blood clotting disorder (such as hemophilia),
• breathing problems or chronic lung disease (such as chronic bronchitis),
• diabetes,
• difficulty in urination due to prostate enlargement,
• glaucoma,
• high blood pressure,
• mild to moderate kidney disease,
• mild to moderate liver disease,
• any other serious disease, are under doctor’s care for any serious condition, or are taking any other drug including over the counter drugs,
• trying to conceive, pregnant or breastfeeding,
• each 200 mg caplet contains 22 mg of sodium. This should IMPORTANT: PLEASE READ

Haleon Canada ULC Page 56 of 63

be taken into consideration in a sodium restricted diet.

The use of NSAIDs, like Advil Headache & Migraine Caplets, 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.

Stop use and ask a doctor if

• you show signs of stomach bleeding
• pain worsens or lasts more than 5 days
• fever worsens or lasts more than 3 days
• any new symptoms appear

Long-term continuous use may increase the risk of heart attack or stroke.

INTERACTIONS WITH THIS MEDICATION

Do not use this product if you are taking:

• Daily low dose ASA (81 – 325 mg), without talking to a

  doctor or pharmacist. Ibuprofen may interfere with the preventative benefits of ASA.

• ASA or other anti-inflammatory medication.

Drugs that may interact with Advil Headache & Migraine Caplets include:

• Acetaminophen
• Acetylsalicylic acid (ASA)
• Anticoagulants (blood thinning medications)
• Anti-hypertensives (blood pressure medications)
• Benzodiazepines
• Corticosteroids
• Cyclosporine

• Diabetes medication (including insulin and oral

  antidiabetic agents)

• Digoxin
• Diuretics (water pills)
• Drugs for depression
• Lithium
• Methotrexate

• Nonsteroidal anti-inflammatory drugs (NSAIDs);

  including naproxen and ibuprofen

• Phenytoin
• Protein-bound drugs (including probenecid)
• Thyroxine

Tell your doctor or pharmacist what prescription or non-prescription drugs you are taking or plan to take.

Do not smoke or drink alcohol while using this product.

PROPER USE OF THIS MEDICATION

Usual dose:

Adults and Children 12 years and over: Take 1 caplet every 4 hours or 2 caplets every 6 to 8 hours as needed. Do not exceed 6 caplets in 24 hours, unless directed by a physician.

Do not use longer than 5 days for pain relief.

Do not use for longer than 3 days for fever.

Overdose:

In case of overdose, call a Poison Control Centre or a doctor immediately, even if there are no symptoms.

Missed Dose:

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take your medicine and skip the missed dose. Do not take twice the recommended dose following a missed dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Advil Headache & Migraine Caplets may occasionally produce unwanted side effects, such as heartburn, constipation, nausea, bloating, nervousness or sleeplessness.

Stop use and contact a doctor or pharmacist if these symptoms worsen or persist.

The risk of having side effects may be decreased by using the smallest dose for the shortest duration of time.

IMPORTANT: PLEASE READ

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This is not a complete list of side effect. For any unexpected effects while taking Advil Headache & Migraine Caplets, contact your doctor or pharmacist.

HOW TO STORE IT

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

  (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) 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.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Haleon Canada ULC, Mississauga, ON L5R 4B2, at: 1-888-275-9938 or www.advil.ca.

Product monograph available to physicians and pharmacists upon request.

Date of Authorization: November 20, 2025