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Details for: EXTRA STRENGTH IBUPROFEN LIQUID CAPSULES

Company: VITA HEALTH PRODUCTS INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02357283EXTRA STRENGTH IBUPROFEN LIQUID CAPSULESIBUPROFEN400 MGCAPSULEORAL
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Summary Reports

Summary Safety Review - Prescription Oral Ibuprofen (Non-Steroidal Anti-inflammatory Drug) - Risk of Serious Heart and Stroke Adverse Events at High Doses

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

For 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 reduces pain and fever.

When it should not be used

Do not take Ibuprofen Liquid 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 Ibuprofen Liquid 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 Liquid 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 (present as free acid and potassium salt).

What the non-medicinal ingredients are

FD&C green No. 3, gelatin, isopropyl alcohol, medium chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol.

What dosage form it comes in

Each capsule contains 200 mg ibuprofen (present as free acid and potassium salt).

Warnings and precautions

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 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

Do not use Ibuprofen Liquid Capsules 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

Usual Dose

Adults and children over 12: Take 1 (every 4 hours) or 2 (every 6 to 8 hours) capsules as needed. Do not exceed 6 capsules in 24 hours, unless directed by a physician.

Do not use longer than 3 days for a fever or 5 days for pain relief. Do not give to children under 12.

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 two doses at the same time.

Side effects and what to do about them

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 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 Capsules, contact your doctor or pharmacist.

How to store

Store at room temperature (15°C -30°C). Protect from light.

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:

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

This leaflet was prepared by Vita Health Products Inc.
Last revised: March 17, 2020

Date modified: