Advil Headache & Migraine Pain 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 Pain also provides 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 Pain 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 Pain’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), uticaria/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),
  • Sytemic Lupus Erythematosus,

  • pregnant or nursing.

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 Pain Tablets and Caplets contain ibuprofen 200 mg, provided as 256 mg ibuprofen sodium dihydrate.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

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

• 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,
• each 200 mg tablet/caplet contains 22 mg of sodium. This should be taken into consideration in a sodium restricted diet.

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 Pain 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 or tablet every 4 hours or 2 caplets or tablets every 6 to 8 hours as needed. Do not exceed 6 tablets or 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:

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 Pain 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.

This is not a complete list of side effect. For any unexpected effects while taking Advil® Headache & Migraine Pain, 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

MORE INFORMATION

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

Product monograph available to physicians and pharmacists upon request.

Last revised: 29-July-2016