Patient Medication Information: uses, side effects, how to take - Ibuprofen Capsules, 200mg
What the medication is used for:
Temporary relief of mild to moderate migraine headaches including associated symptoms of nausea, and sensitivity to light and sound.
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, dental pain, menstrual pain, aches and pain due to the common cold and flu and for reduction of fever.
What it does:
IBUPROFEN CAPSULES, 200 mgare a non-steroidal anti-inflammatory drug (NSAID) that can reduce the chemicals produced by your body which cause pain and inflammation.
When it should not be used:
Do not take IBUPROFEN CAPSULES, 200 mg if you have or are:
- active or recurrent stomach ulcer, gastrointestinal (GI) bleeding, or active inflammatory bowel disease (e.g. Crohn’s, colitis),
- taking acetylsalicylic acid (ASA) or any NSAIDs including any other ibuprofen product,
- allergic/hypersensitive to ASA, ibuprofen, other salicylates, other NSAIDs or any of Ibuprofen Capsules ingredients (Refer to the nonmedicinal ingredients on 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,
- right before or after heart surgery,
- serious liver or kidney disease,
high potassium in the blood,
- Systemic Lupus Erythematosus,
or if you are in your third trimester of pregnancy.
IBUPROFEN CAPSULES, 200 mg should NOT be used in patients under 12 years of age since the safety and effectiveness have NOT been established.
What the medicinal ingredients are:
Ibuprofen (present as free acid and potassium salt).
What the important nonmedicinal ingredients are:
FD&C Blue #1, gelatin, lecithin, medium chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol.
What dosage forms it comes in:
Each liquid filled capsule contains ibuprofen 200mg (present as free acid and potassium salt).
Serious Warnings and Precautions
- Caution in those with heart failure, high blood pressure or other conditions that may cause excess fluid collecting in tissues.
- Caution in patients prone to 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 patients at risk of kidney problems, including the elderly or those using diuretics.
- Stop use immediately if you have difficulty or pain when urinating.
- IBUPOFEN CAPSULES, 200 mg should not be used during third trimester of.
- Talk to your doctor if you are trying to conceive, in your first or second trimester of pregnancy or if breastfeeding.
BEFORE you use IBUPROFEN CAPSULES,200 mg talk to your doctor or pharmacist if:
- you have previous or current stomach ulcers, diabetes, high blood pressure, heart failure, heart disease or thyroid disease, asthma, kidney or liver disease, glaucoma, blood clotting disorder (such as hemophilia), any other serious disease, are under doctor’s care for any serious condition, are trying to conceive, pregnant or breastfeeding or are taking any other drug including over the counter drugs.
Use with caution in the elderly.
Long-term continuous use may increase the risk of heart attack or stroke.
The use of NSAIDs, like IBUPROFEN CAPSULES, 200 mg, in the second trimester of pregnancy should be restricted to the lowest dose necessary for the shortest possible duration.
WARNINGS AND PRECAUTIONS
ABOUT THIS MEDICATION
IMPORTANT: PLEASE READ
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
Do not use IBUPROFEN CAPSULES, 200 mg if you are taking:
- Daily low dose ASA (81 – 325 mg), without talking to a doctor or pharmacist. Ibuprofen may interfere with the preventive benefits of ASA.
- ASA or other anti-inflammatory medication.
Talk to your doctor or pharmacist if you are taking other medication (prescription or non-prescription) such as any of the following (NOT a complete list): acetaminophen, anticoagulants (blood thinners), digoxin, oral antidiabetic agents and insulin, diuretics, methotrexate, lithium, protein-bound drugs including probenecid, thyroxine, antibiotics, cyclosporine, phenytoin, corticosteroids or benzodiazepines, other NSAIDs, or medications for high blood pressure. Tell your doctor or pharmacist what prescription drugs you are taking or plan to take.
Usual dose:
For migraine headaches: Adults and children over 12 years: Take 1 (every 4 hours) or 2 (every 6-8 hours) capsules at the first sign of symptoms as needed. Do not exceed 6 capsules in 24 hours, unless directed by a doctor.
For all other uses: Adults and children over 12 years: Take 1 (every 4 hours) or 2 (every 6-8 hours) capsules as needed. Do not exceed 6 capsules in 24 hours, unless directed by a doctor.
Do not use longer than 3 days for a fever or 5 days for pain relief. Do not give to children under 12.
Overdose:
| If you think you, or a person you are caring for, have taken too much IBUPROFEN CAPSULES, 200 mg, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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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 two doses at the same time.
Take with food or milk if upset stomach occurs.
If abdominal pain, heartburn, nausea or vomiting, bloating, diarrhea or constipation, ringing or buzzing in the ears, nervousness, sleeplessness, dizziness or any change in vision, itching, fluid retention, shortness of breath, wheezing, any trouble breathing or chest tightness, hives, swelling or itching, skin rashes, skin reddening, blisters, blood in vomit, bloody or black stools, jaundice (yellowing of the eyes or skin due to liver problem), or any other side effect or unexplained symptoms develop while taking IBUPROFEN CAPSULES, 200 mg discontinue use immediately and contact a doctor.
Side effects may be minimized by using the smallest dose for the shortest duration of time.
This is not a complete list of side effects. For any unexpected effects while taking IBUPROFEN CAPSULES,200 mg contact your doctor or pharmacist.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
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Store at controlled room temperature, 20°- 25°C, protect from high humidity and light. Keep out of reach of children. This package contains enough medicine to seriously harm a child.
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes the Consumer 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 contacting the sponsor, Bionpharma Inc. at 1-888-235-2466.
Date of Authorization: May 23, 2025