Details for: EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02376601 | EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES | IBUPROFEN | 400 MG | CAPSULE | 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 LIQUID GEL CAPSULES
200 mg Ibuprofen Capsules (free acid and potassium salt)
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.
EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES
400 mg Ibuprofen Capsules (free acid and potassium
salt)
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. Clinical studies show long lasting pain relief for
up to 8 hours.
What it does
IBUPROFEN LIQUID GEL CAPSULES
200 mg Ibuprofen Capsules (free acid and potassium salt)
Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) that can reduce the chemicals produced by your body which cause pain and inflammation.
EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES
400 mg Ibuprofen Capsules (free acid and potassium
salt)
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that can reduce the chemicals produced by your body which cause pain and inflammation.
When it should not be used
IBUPROFEN LIQUID GEL CAPSULES
200 mg Ibuprofen Capsules (free acid and potassium salt)
Do not take IBUPROFEN LIQUID GEL CAPSULES 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 LIQUID GEL 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,
- serious liver or kidney disease,
- Systemic Lupus Erythematosus,
- or if you are in your third trimester of pregnancy.
IBUPROFEN LIQUID GEL CAPSULES should NOT be used in patients under 12 years of age since the safety and effectiveness have NOT been established.
EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES
400 mg Ibuprofen Capsules (free acid and potassium
salt)
Do not take EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES 400 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 of EXTRA STRENGTH IBUPROFEN LIQUID GEL 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
- high potassium in the blood
- serious liver or kidney disease,
- Systemic Lupus Erythematosus,
- or if you are in your third trimester of pregnancy
EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES 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 LIQUID GEL CAPSULES
200 mg Ibuprofen Capsules (free acid and potassium salt)
Ibuprofen (free acid and potassium salt).
EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES
400 mg Ibuprofen Capsules (free acid and potassium
salt)
Ibuprofen (free acid and potassium salt).
What the non-medicinal ingredients are
IBUPROFEN LIQUID GEL CAPSULES
200 mg Ibuprofen Capsules (free acid and potassium salt)
This is a complete listing of non-medicinal ingredients (in alphabetical order): FD&C Green No. 3 (gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, propylene glycol, purified water, sorbitol sorbitan solution.
EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES
400 mg Ibuprofen Capsules (free acid and potassium
salt)
This is a complete listing of non-medicinal ingredients (in alphabetical order): gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, propylene glycol, purified water, sorbitol sorbitan solution.
What dosage form it comes in
IBUPROFEN LIQUID GEL CAPSULES
200 mg Ibuprofen Capsules (free acid and potassium salt)
Capsules, 200 mg
EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES
400 mg Ibuprofen Capsules (free acid and potassium
salt)
Capsules, 400 mg
Warnings and precautions
200 mg Ibuprofen Capsules (free acid and potassium salt)
EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES
400 mg Ibuprofen Capsules (free acid and potassium salt)
IBUPROFEN LIQUID GEL CAPSULES
200 mg Ibuprofen Capsules (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.
- Use during pregnancy or nursing should be avoided.
Before you use IBUPROFEN LIQUID GEL CAPSULES 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 if you are 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.
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
EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES
400 mg Ibuprofen Capsules (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.
- Use during pregnancy or nursing should be avoided.
BEFORE you use EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES 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 if you are 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.
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
Interactions with this medication
IBUPROFEN LIQUID GEL CAPSULES
200 mg Ibuprofen Capsules (free acid and potassium salt)
Do not use IBUPROFEN LIQUID GEL 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.
EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES
400 mg Ibuprofen Capsules (free acid and potassium
salt)
Do not use EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES 400 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.
Proper use of this medication
200 mg Ibuprofen Capsules (free acid and potassium salt)
EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES
400 mg Ibuprofen Capsules (free acid and potassium salt)
IBUPROFEN LIQUID GEL CAPSULES
200 mg Ibuprofen Capsules (free acid and potassium salt)
Usual dose
IBUPROFEN LIQUID GEL CAPSULES 200 mg
For migraine headaches: Adults and children 12 years
and over: 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 12 years and over:
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 have taken too much IBUPROFEN LIQUID GEL CAPSULES, contact your healthcare professional, hospital emergency department or regional poison control centre 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.
EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES
400 mg Ibuprofen Capsules (free acid and
potassium
salt)
Usual dose
For migraine headaches: Adults and children 12 years
and over: Take 1 EXTRA STRENGTH IBUPROFEN
LIQUID GEL CAPSULE 400 mg at the first sign of
symptoms and every 6-8 hours as needed. Do not exceed 3 capsules in 24 hours, unless directed by a
doctor.
For all other uses: Adults and children 12 years and over:
Take 1 EXTRA STRENGTH IBUPROFEN LIQUID
GEL CAPSULE 400 mg every 6-8 hours capsules as
needed. Do not exceed 3 capsules in 24 hours, unless
directed by a doctor.
Do not use longer than 3 days for a fever or 5 daysfor
pain relief. Do not give to children under 12.
Overdose
If you think you have taken too much EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULE, contact your healthcare professional, hospital emergency department or regional poison control centre 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 LIQUID GEL CAPSULES
200 mg Ibuprofen Capsules (free acid and potassium salt)
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 LIQUID
GEL CAPSULES, 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 LIQUID
GEL CAPSULES, contact your doctor or pharmacist.
EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES
400 mg Ibuprofen Capsules (free acid and potassium
salt)
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 EXTRA STRENGTH
IBUPROFEN LIQUID GEL CAPSULE, 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 EXTRA STRENGTH
IBUPROFEN LIQUID GEL CAPSULE 400 mg, contact
your doctor or pharmacist.
How to store
IBUPROFEN LIQUID GEL CAPSULES
200 mg Ibuprofen Capsules (free acid and potassium salt)
Store at room temperature between 15°C to 25°C.
Protect from heat and humidity.
Caution: Keep out of reach of children.This
package contains enough medicine to seriously harm
a child.
EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES
400 mg Ibuprofen Capsules (free acid and potassium
salt)
Store at room temperature between 15°C to 25°C.
Protect from heat and humidity.
Caution: Keep out of 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 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/adverse-reaction-reporting.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 health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
IBUPROFEN LIQUID GEL CAPSULES
200 mg Ibuprofen Capsules (free acid and potassium salt)
If you want more information about IBUPROFEN LIQUID GEL CAPSULES:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); Find the Consumer Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800- 667-4708.
This leaflet was prepared by Apotex Inc., Toronto,
Ontario, M9L 1T9.
Date of Revision: June 8, 2020
EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES
400 mg Ibuprofen Capsules (free acid and potassium
salt)
If you want more information about EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp). Find the Consumer Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800- 667-4708.
This leaflet was prepared by Apotex Inc., Toronto,
Ontario, M9L 1T9.
Date of Revision: June 8, 2020