Details for: IBUPROFEN CAPLETS 200 MG
Company: VITA HEALTH PRODUCTS INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02272857 | IBUPROFEN CAPLETS 200 MG | IBUPROFEN | 200 MG | TABLET | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
IBUPROFEN TABLETS 200 MG
Ibuprofen Tablets USP
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, menstrual pain, aches and pain due to the common cold and flu and for reduction of fever.
IBUPROFEN CAPLETS 200 MG
Ibuprofen Tablets USP
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, menstrual pain, aches and pain due to the common cold and flu and for reduction of fever.
What it does
IBUPROFEN TABLETS 200 MG
Ibuprofen Tablets USP
Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) that
can reduce the chemicals produced by your body which cause
pain and inflammation.
Ibuprofen can only relieve pain and reduce swelling as long as
you continue to take it.
IBUPROFEN CAPLETS 200 MG
Ibuprofen Tablets USP
Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) that
can reduce the chemicals produced by your body which cause
pain and inflammation.
Ibuprofen can only relieve pain and reduce swelling as long as
you continue to take it.
When it should not be used
IBUPROFEN TABLETS 200 MG
Ibuprofen Tablets USP
Do not take Ibuprofen Tablets 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 other NSAIDs including any other ibuprofen product,
- allergic/hypersensitive to ASA, ibuprofen, other salicylates, other NSAIDs or any Ibuprofen Tablets 200 mg ingredients (refer to the non-medicinal 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,
- Systemic Lupus Erythematosus,
- or if you are in your third trimester of pregnancy.
Ibuprofen Tablets 200 mg should NOT be used in patients under 12 years of age since the safety and effectiveness have NOT been established.
IBUPROFEN CAPLETS 200 MG
Ibuprofen Tablets USP
Do not take Ibuprofen Caplets 200 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 other NSAIDs including any other ibuprofen product,
- allergic/hypersensitive to ASA, ibuprofen, other salicylates, other NSAIDs or any Ibuprofen Caplets 200 mg ingredients (refer to the non-medicinal 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,
- Systemic Lupus Erythematosus,
- or if you are in your third trimester of pregnancy.
Ibuprofen Caplets 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 ingredient is
IBUPROFEN TABLETS 200 MG
Ibuprofen Tablets USP
Ibuprofen
IBUPROFEN CAPLETS 200 MG
Ibuprofen Tablets USP
Ibuprofen
What the non-medicinal ingredients are
IBUPROFEN TABLETS 200 MG
Ibuprofen Tablets USP
Carnauba wax, colloidal silicon dioxide, corn starch, hydroxypropyl methylcellulose, iron oxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, purified water, sodium lauryl sulphate, sodium starch glycolate, titanium dioxide.
IBUPROFEN CAPLETS 200 MG
Ibuprofen Tablets USP
Carnauba wax, colloidal silicon dioxide, corn starch, hydroxypropyl methylcellulose, iron oxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, purified water, sodium lauryl sulphate, sodium starch glycolate, titanium dioxide.
What dosage form it comes in
IBUPROFEN TABLETS 200 MG
Ibuprofen Tablets USP
Ibuprofen Tablet 200 mg
IBUPROFEN CAPLETS 200 MG
Ibuprofen Tablets USP
Ibuprofen Caplet 200 mg
Warnings and precautions
Ibuprofen Tablets USP
IBUPROFEN CAPLETS 200 MG
Ibuprofen Tablets USP
IBUPROFEN TABLETS 200 MG
Ibuprofen Tablets USP
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 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 patients at risk of kidney problems, including the elderly or those using diuretics.
- Stop use immediately if you have difficulty or pain when urinating.
- Use during pregnancy or nursing should be avoided.
BEFORE you use Ibuprofen Tablets 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, you are trying to conceive, in your first or second trimester of pregnancy 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.
IBUPROFEN CAPLETS 200 MG
Ibuprofen Tablets USP
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 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 patients at risk of kidney problems, including the elderly or those using diuretics.
- Stop use immediately if you have difficulty or pain when urinating.
- Use during pregnancy or nursing should be avoided.
BEFORE you use Ibuprofen Caplets 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, you are trying to conceive, in your first or second trimester of pregnancy 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.
Interactions with this medication
IBUPROFEN TABLETS 200 MG
Ibuprofen Tablets USP
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.
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.
IBUPROFEN CAPLETS 200 MG
Ibuprofen Tablets USP
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.
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.
Proper use of this medication
IBUPROFEN TABLETS 200 MG
Ibuprofen Tablets USP
Usual dose
Adults and children over 12: Take 1 (every 4 hours) or 2 (every 6 to 8 hours) tablets as needed. Do not exceed 6 tablets in 24 hours, unless directed by a physician. Do not use longer than 3 days for fever or 5 days for pain relief.
Overdose
In case of overdose, contact a Poison Control Centre or 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 two doses at the same time.
IBUPROFEN CAPLETS 200 MG
Ibuprofen Tablets USP
Usual dose
Adults and children over 12: Take 1 (every 4 hours) or 2 (every 6 to 8 hours) caplets as needed. Do not exceed 6 caplets in 24 hours, unless directed by a physician. Do not use longer than 3 days for fever or 5 days for pain relief.
Overdose
In case of overdose, contact a Poison Control Centre or 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 two doses at the same time.
Side effects and what to do about them
IBUPROFEN TABLETS 200 MG
Ibuprofen Tablets USP
Take with food or milk if upset stomach occurs. If abdominal
pain, heartburn, nausea or vomiting, bloating, diarrhea or
constipation, ringing or buzzing in 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, bloodyor 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, discontinue use immediately and contact a
physician.
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 Tablets 200 mg, contact your
doctor or pharmacist.
IBUPROFEN CAPLETS 200 MG
Ibuprofen Tablets USP
Take with food or milk if upset stomach occurs. If abdominal
pain, heartburn, nausea or vomiting, bloating, diarrhea or
constipation, ringing or buzzing in 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, discontinue use immediately and contact a
physician.
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 IbuprofenCaplets 200 mg, contact your
doctor or pharmacist.
How to store
IBUPROFEN TABLETS 200 MG
Ibuprofen Tablets USP
Store at room temperature (15°C-30°C).
Keep out of the reach of children. This package contains enough
medicine to seriously harm a child.
IBUPROFEN CAPLETS 200 MG
Ibuprofen Tablets USP
Store at room temperature (15°C-30°C).
Keep out of the reach of children. This package contains enough
medicine to seriously harm a child.
Reporting side effects
Reporting Side Effects
You can report any suspected side effects associated with the use of health productsto Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting
(http://www.hc-sc.gc.ca/dhp-mps/medeff/reportdeclaration/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:
Regulatory Affairs Department
Vita Health Products Inc.
150 Beghin Avenue
Winnipeg, Manitoba
R2J 3W2
1-800-665-8820
This leaflet was prepared by Vita Health Products Inc.
Last revised: July 7, 2021