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Details for: MOTRIN LIQUID GELS 200MG

Company: MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02297582MOTRIN LIQUID GELS 200MGIBUPROFEN200 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

MOTRIN® LIQUID GELS 200 mg
Ibuprofen Capsules (free acid and potassium salt)

MOTRIN® Liquid Gels 200 mg provides fast and effective relief of pain from:

  • muscle aches and pain, joint and body pain, backache, muscle sprains and strains,
  • pain of inflammation associated with conditions including:
    • arthritis,
    • 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.

Temporary relief of mild to moderate migraine headaches including associated symptoms of nausea, and sensitivity to light and sound.

Reduction of fever.

MOTRIN® LIQUID GELS 400 mg
Ibuprofen Capsules (free acid and potassium salt)

MOTRIN® Liquid Gels 400 mg provides fast and effective relief of pain from:

  • muscle aches and pain, joint and body pain, backache, muscle sprains and strains,
  • pain of inflammation associated with conditions including:
    • arthritis,
    • 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.

Temporary relief of mild to moderate migraine headaches including associated symptoms of nausea, and sensitivity to light and sound.

Clinical studies show long lasting pain relief up to 8 hours.

Reduction of fever.

What it does

MOTRIN® LIQUID GELS 200 mg
Ibuprofen Capsules (free acid and potassium salt)

MOTRIN® (ibuprofen) Liquid Gels 200 mg starts to work fast and treats pain where it starts. Ibuprofen is a member of a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs work within the body by blocking the production of substances, called prostaglandins, which are involved in the development of pain and inflammation.

MOTRIN® LIQUID GELS 400 mg
Ibuprofen Capsules (free acid and potassium salt)

MOTRIN® (ibuprofen) Liquid Gels 400 mg starts to work fast and treats pain where it starts. Ibuprofen is a member of a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs work within the body by blocking the production of substances, called prostaglandins, which are involved in the development of pain and inflammation.

When it should not be used

MOTRIN® LIQUID GELS 200 mg
Ibuprofen Capsules (free acid and potassium salt)

MOTRIN® Liquid Gels 200 mg should not be used if you:

  • are taking acetylsalicylic acid (ASA) or any other nonsteroidal anti-inflammatory medication including any other ibuprofen product.
  • are allergic or have had a reaction to ibuprofen, acetylsalicylic acid (ASA), other non-steroidal antiinflammatory drugs (NSAIDs) or salicylates, or to any ingredient in the formulation (see non-medicinal ingredients below). Allergic reactions may appear as hives, difficulty breathing, shock, skin reddening, rash or blisters, swelling of the face or throat, or sudden collapse.
  • have nasal polyps (swelling of the inside of the nose), or allergic manifestations such as asthma, anaphylaxis (sudden severe life-threatening anaphylactic reactions), urticaria/hives, rhinitis (stuffed or runny nose that may be due to allergies), skin rash or other allergic symptoms.
  • have been diagnosed with severe high blood pressure or have severe coronary artery disease.
  • are dehydrated (significant fluid loss) due to vomiting, diarrhea or lack of fluid intake.
  • have active or recurrent stomach ulcer, gastrointestinal (GI) bleeding, or active inflammatory bowel disease (e.g. Crohn’s, colitis).
  • have serious liver or kidney disease.
  • have systemic lupus erythematosus.
  • are in your third trimester of pregnancy.
  • recently had or are about to have heart surgery.
  • have high potassium in the blood.

MOTRIN® LIQUID GELS 400 mg
Ibuprofen Capsules (free acid and potassium salt)

MOTRIN® Liquid Gels 400 mg should not be used if you:

  • are taking acetylsalicylic acid (ASA) or any other nonsteroidal anti-inflammatory medication, including any other ibuprofen product.
  • are allergic or have had a reaction to ibuprofen, acetylsalicylic acid (ASA), other non-steroidal antiinflammatory drugs (NSAIDs) or salicylates, or to any ingredient in the formulation (see non-medicinal ingredients below). Allergic reactions may appear as hives, difficulty breathing, shock, skin reddening, rash or blisters, swelling of the face or throat, or sudden collapse.
  • have nasal polyps (swelling of the inside of the nose), or allergic manifestations such as asthma, anaphylaxis (sudden severe life-threatening anaphylactic reactions), urticaria/hives, rhinitis (stuffed or runny nose that may be due to allergies), skin rash or other allergic symptoms.
  • have been diagnosed with severe high blood pressure or have severe coronary artery disease.
  • are dehydrated (significant fluid loss) due to vomiting, diarrhea or lack of fluid intake.
  • have active or recurrent stomach ulcer, gastrointestinal (GI) bleeding, or active inflammatory bowel disease (e.g. Crohn’s, colitis).
  • have serious liver or kidney disease.
  • have systemic lupus erythematosus.
  • are in your third trimester of pregnancy.
  • recently had or are about to have heart surgery.
  • have high potassium in the blood
What the medicinal ingredient is

MOTRIN® LIQUID GELS 200 mg
Ibuprofen Capsules (free acid and potassium salt)

Ibuprofen (free acid and potassium salt).

MOTRIN® LIQUID GELS 400 mg
Ibuprofen Capsules (free acid and potassium salt)

Ibuprofen (free acid and potassium salt).

What the non-medicinal ingredients are

MOTRIN® LIQUID GELS 200 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 and sorbitol.

MOTRIN® LIQUID GELS 400 mg
Ibuprofen Capsules (free acid and potassium salt)

This is a complete listing of non-medicinal ingredients: gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, propylene glycol, purified water, sorbitol.

What dosage form it comes in

MOTRIN® LIQUID GELS 200 mg
Ibuprofen Capsules (free acid and potassium salt)

Capsules, 200 mg

MOTRIN® LIQUID GELS 400 mg
Ibuprofen Capsules (free acid and potassium salt)

Capsules, 400 mg

Warnings and precautions
MOTRIN® LIQUID GELS 200 mg
Ibuprofen Capsules (free acid and potassium salt)


MOTRIN® LIQUID GELS 400 mg
Ibuprofen Capsules (free acid and potassium salt)

MOTRIN® LIQUID GELS 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 breastfeeding should be avoided.

BEFORE you use MOTRIN® Liquid Gels 200 mg talk to your doctor or pharmacist if you:

  • have previous or current stomach ulcers, high blood pressure, asthma, heart failure, heart disease or thyroid disease, kidney or liver disease, glaucoma, diabetes, alcoholism, a history of stomach bleeding, or any other serious disease or condition.
  • are taking any drug including over the counter drugs.
  • are trying to conceive, in your first or second trimester of pregnancy or breastfeeding.
  • have a blood-clotting disorder (e.g. hemophilia, sickle cell anemia, etc.).
  • are on a special diet (e.g. low-sodium).

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

MOTRIN® LIQUID GELS 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 breastfeeding should be avoided.

BEFORE you use MOTRIN® Liquid Gels 400 mg talk to your doctor or pharmacist if you:

  • have previous or current stomach ulcers, high blood pressure, asthma, heart failure, heart disease or thyroid disease, kidney or liver disease, glaucoma, diabetes, alcoholism, a history of stomach bleeding, or any other serious disease or condition.
  • are taking any drug including over the counter drugs.
  • are trying to conceive, in your first or second trimester of pregnancy or breastfeeding.
  • have a blood-clotting disorder (e.g. hemophilia, sickle cell anemia, etc.).
  • are on a special diet (e.g. low-sodium).

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

MOTRIN® LIQUID GELS 200 mg
Ibuprofen Capsules (free acid and potassium salt)

Do not use MOTRIN® Liquid Gels 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.

Drugs that may interact with MOTRIN® Liquid Gels 200 mg include: 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.

MOTRIN® LIQUID GELS 400 mg
Ibuprofen Capsules (free acid and potassium salt)

Do not use MOTRIN® Liquid Gels 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.

Drugs that may interact with MOTRIN® Liquid Gels 400 mg include: 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
MOTRIN® LIQUID GELS 200 mg
Ibuprofen Capsules (free acid and potassium salt)


MOTRIN® LIQUID GELS 400 mg
Ibuprofen Capsules (free acid and potassium salt)

MOTRIN® LIQUID GELS 200 mg
Ibuprofen Capsules (free acid and potassium salt)

Stomach upset is one of the common problems with NSAIDs. To lessen stomach upset, take this medicine immediately after a meal or with food or milk. If stomach upset (indigestion, nausea, vomiting, stomach pain or diarrhoea) occurs and continues, contact your doctor.

Usual dose

Children’s MOTRIN® formulations are available to treat children under 12 years of age.

For migraine headaches: Adults and children over 12: Take 1(every 4 hours) or 2 (every 6-8 hours) capsules at the first sign of symptoms as needed. Do not exceed six capsules in 24 hours, unless directed by a doctor.

For all other uses: Adults and children over 12: 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. Use the lowest effective dose for the shortest duration.

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.

MOTRIN® LIQUID GELS 400 mg
Ibuprofen Capsules (free acid and potassium salt)

Stomach upset is one of the common problems with NSAIDs. To lessen stomach upset, take this medicine immediately after a meal or with food or milk. If stomach upset (indigestion, nausea, vomiting, stomach pain or diarrhoea) occurs and continues, contact your doctor.

Usual Dose

Children’s MOTRIN® formulations are available to treat children under 12 years of age.

For migraine headaches: Adults and children over 12: Take 1 capsule 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 over 12: Take 1 capsule every 6-8 hours 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 days for pain relief. Do not give to children under 12. Use the lowest effective dose for the shortest duration.

Overdose

In case of overdose, call a Poison Control Centre or a doctor immediately, even if there are no symptoms.

Missed Dose

If a dose is missed, resume dosing on the normal schedule without exceeding the maximum allowed for 24 hours.

Side effects and what to do about them
MOTRIN® LIQUID GELS 200 mg
Ibuprofen Capsules (free acid and potassium salt)


MOTRIN® LIQUID GELS 400 mg
Ibuprofen Capsules (free acid and potassium salt)

MOTRIN® LIQUID GELS 200 mg
Ibuprofen Capsules (free acid and potassium salt)

The most common side effects with this medication are indigestion, nausea, or vomiting, heartburn, dizziness, and skin rashes.

The other side effects, which might be seen, are sudden abdominal pain or long-term abdominal pain with the loss of appetite and/or jaundice and/or new onset of itching, diarrhoea, bloating, constipation, abdominal cramp, headache, nervousness, drowsiness, itching, decreased appetite, sleeplessness and fluid retention.

If unusual symptoms or any of the following reactions develop during treatment, stop use and see a doctor immediately.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and seek immediate emergency medical attention
Uncommon
Chills, fever, muscle aches or pains, or other flu-like symptoms shortly before or together with a skin rash    
Bloody or black tarry stools    
Hives or itching, skin reddening, blisters    
Blurred vision    
Swelling of feet or lower legs    
Hearing problems (ringing or buzzing in the ears)    
Mental confusion or depression    
Shortness of breath, trouble breathing, asthma, sinusitis (nasal congestion), wheezing, or tightness in the chest    
Vomiting blood    
Yellow discoloration of the skin or eyes, with or without fatigue    
Any changes in the amount or colour of your urine (such as dark; red or brown), any pain or difficulty experienced in urination, loss of appetite, dizziness, or light headedness    
Stomach pain    
Heart Failure    

In addition to checking with your doctor, if these serious side effects occur, stop taking this medication.

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 MOTRIN® Liquid Gels 200 mg, contact your doctor or pharmacist.

MOTRIN® LIQUID GELS 400 mg
Ibuprofen Capsules (free acid and potassium salt)

Along with its needed effects, MOTRIN® Liquid Gels 400 mg like other NSAIDs may cause some unwanted effects especially when used for a long time or in large doses. However, at the maximum daily dose of 1200 mg, there are very few side effects seen and these are primarily only gastrointestinal.

The most common side effects with this medication are indigestion, nausea, vomiting, heartburn, dizziness, and skin rashes.

The other side effects, which might be seen, are sudden abdominal pain or long-term abdominal pain with the loss of appetite and/or jaundice and/or new onset of itching, diarrhoea, flatulence, constipation, abdominal cramp, headache, nervousness, drowsiness, itching, decreased appetite, sleeplessness and fluid retention.

If unusual symptoms or any of the following reactions develop during treatment, stop use and see a doctor immediately.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and seek immediate emergency medical attention
Uncommon
Chills, fever, muscle aches or pains, or other flu-like symptoms shortly before or together with a skin rash    
Bloody or black tarry stools    
Hives or itching, skin reddening, blisters    
Blurred vision    
Swelling of feet or lower legs    
Hearing problems (ringing or buzzing in the ears)    
Mental confusion or depression    
Shortness of breath, trouble breathing, asthma, sinusitis (nasal congestion), wheezing, or tightness in the chest    
Vomiting blood    
Yellow discoloration of the skin or eyes, with or without fatigue    
Any changes in the amount or colour of your urine (such as dark; red or brown), any pain or difficulty experienced in urination, loss of appetite, dizziness, or light headedness    
Stomach pain    
Heart Failure    

In addition to checking with your doctor, if these serious side effects occur, stop taking this medication.

This is not a complete list of side effects. For any unexpected effects while taking MOTRIN® Liquid Gels 400 mg, contact your doctor or pharmacist.

How to store

MOTRIN® LIQUID GELS 200 mg
Ibuprofen Capsules (free acid and potassium salt)

Store at 15 - 30°C. Protect from heat and humidity.

Keep out of reach of children. This package contains enough medicine to seriously harm a child.

MOTRIN® LIQUID GELS 400 mg
Ibuprofen Capsules (free acid and potassium salt)

Store at 15 to 30°C. Protect from heat and humidity.

Keep out of reach of children. This package contains enough medicine to seriously harm a child.

Do not keep outdated medicine or medicine no longer needed.

Reporting side effects

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 obtained by request at www.motrin.ca or by contacting the sponsor, McNeil Consumer Healthcare at:

McNeil Consumer Healthcare,
division of Johnson & Johnson Inc.,
88 McNabb Street
Markham, Canada L3R 5L2
©J&J Inc. 2020
Questions? 1-888-6 MOTRIN / 1-888-666-8746

Date of Revision: February 23, 2021

Date modified: