Details for: MOTRIN
Company: MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02186934 | MOTRIN 200MG | IBUPROFEN | 200 MG | TABLET | ORAL |
| 02242632 | MOTRIN 300MG | IBUPROFEN | 300 MG | TABLET | ORAL |
| 02242658 | MOTRIN 400MG | IBUPROFEN | 400 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
Since everyone’s pain is different, MOTRIN® offers 3
levels of pain relief to suit your needs. So you can
choose your relief, MOTRIN® products are available
in three strengths, including: MOTRIN® 200 mg
(Regular Strength), MOTRIN® 300 mg (Extra
Strength) and MOTRIN® 400 mg (Super Strength)
Tablets.
MOTRIN® products provide fast and effective relief of
PAIN from:
- headache, including mild to moderate migraine and tension headache
- menstrual cramps
- toothache (dental pain), including dental extraction
- inflammation from arthritis, muscle strain and sprains, muscles, bones and joints, including back pain
MOTRIN® is also an effective fever reducer and will
provide relief from the aches and pain due to the
common cold and flu.
Clinical studies show long lasting relief for up to 8
hours for fever and up to 6 hours for pain.
What it does
What it does:
MOTRIN® (ibuprofen) 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® should not be used if you:
- are taking acetylsalicylic acid (ASA) or any other non-steroidal anti-inflammatory medication, including any other ibuprofen product.
- are allergic or have had a reaction to ibuprofen, acetylsalicylic acid (ASA), other non-steroidal anti-inflammatory 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 lifethreatening 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 liver or kidney disease.
- have systemic lupus erythematosus.
- are in your third trimester of pregnancy.
- right before or after heart surgery.
What the medicinal ingredient is
Ibuprofen
What the non-medicinal ingredients are
MOTRIN® 200 mg (Regular Strength) are
white, sweet-coated, easy to swallow tablets,
printed with “Motrin IB” in black ink,
containing: colloidal silicon dioxide, corn
starch, hypromellose, iron oxide black, polyethylene glycol, pregelatinized starch, propylene
glycol, sodium cyclamate, sodium starch glycolate,
stearic acid and titanium dioxide.
MOTRIN® 300 mg (Extra Strength) are light orange,
sweet-coated, easy to swallow tablets, printed with
“MOTRIN 300 mg” in black ink, containing: carnauba
wax, colloidal silicon dioxide, corn starch, FD&C
yellow no. 6, hypromellose, iron oxide black,
polydextrose, polyethylene glycol, propylene glycol,
sodium cyclamate, sodium starch glycolate, stearic
acid, titanium dioxide.
MOTRIN® 400 mg (Super Strength) are orange,
sweet-coated, easy to swallow tablets, printed with
“MOTRIN 400 mg” in black ink, containing: carnauba
wax, colloidal silicon dioxide, corn starch, FD&C
yellow no. 6, hypromellose, iron oxide black,
polydextrose, polyethylene glycol, propylene glycol,
sodium cyclamate, sodium starch glycolate, stearic
acid, titanium dioxide.
What dosage form it comes in
Tablets: 200 mg, 300 mg, 400 mg
Warnings and precautions
Serious Warnings and Precautions
Caution in patients prone to gastrointestinal tract irritation, including those with a history of peptic ulcer
Keep this medication out of the reach of children.
BEFORE you use MOTRIN® talk to your doctor or
pharmacist if you:
- have stomach ulcers, high blood pressure, asthma, heart failure or thyroid disease, kidney or liver disease, glaucoma, diabetes, alcoholism, a history of stomach bleeding, systemic lupus erythematosus, or any other serious disease or condition.
- are taking an anticoagulant (blood thinning medication), oral corticosteroid or any other drug.
- are trying to conceive, in your first or second trimester of pregnancy or nursing.
- are over 65 years of age.
- are taking low-dose ASA.
- suffer from asthma or have nasal polyps (a swelling inside the nose).
- are dehydrated (severe fluid loss).
- have a blood-clotting disorder (e.g. hemophilia, sickle cell anemia, etc.).
- have a heart disease.
- have any unusual urinary symptoms (e.g. bladder problems).
- are on a special diet (e.g. low-sodium).
- suffer from hyperkalemia (high levels of potassium in your blood).
They may recommend an alternative analgesic such
as acetaminophen.
Long-term continuous use may increase the risk
of heart attack or stroke.
Children’s MOTRIN® formulations are
available to treat children under 12 years of
age.
Interactions with this medication
Always tell any doctor, dentist, or pharmacist you
consult that you are taking this medicine.
Drugs that may interact with MOTRIN® include:
acetylsalicylic acid (ASA) or other NSAIDs, blood
thinning medications (anticoagulants), blood pressure
medication (anti-hypertensives), diuretics (water
pills), oral steroids (glucocorticoids), lithium,
diabetes medications (hypoglycemics), methotrexate,
phenytoin, acetaminophen and digoxin.
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.
Proper use of this medication
Usual Dose
For accurate dosing of each product strength, refer to the dosage table and follow the instructions carefully.
| PRODUCT | STRENGTH (IBUPROFEN MG/TABLET) | SINGLE ORAL DOSE | MAXIMUM DAILY DOSE (1200 MG) |
|---|---|---|---|
| (Regular
Strength) MOTRIN® 200 mg |
200 mg | 1 or 2 tablets | 6 tablets |
| (Extra
Strength) MOTRIN® 300 mg |
300 mg | 1 tablet | 4 tablets |
|
(Super
Strength) MOTRIN® 400 mg |
400 mg | 1 tablet | 3 tablets |
The single oral dose may be taken every 4-6 hours as
needed. Do not take more than the maximum daily dose
(1200 mg in 24 hours) unless advised by a doctor. Take
with food or milk if mild stomach upset occurs with use.
MOTRIN® should not be taken for pain for more than 5
consecutive days or for fever for more than 3 days
without first talking to your doctor or dentist.
Use the lowest effective dose for the shortest duration.
Do not take this product while taking ASA, other
ibuprofen containing products or any other pain or
fever medicine.
For effective use of this medicine, unless recommended
by your doctor or dentist, DO NOT take:
- more than the recommended number of tablets in each single dose
- this product longer than the recommended period of time
Overdose
In case of overdose, even if there are no symptoms, call a doctor or Poison Control Centre at once.
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
If unusual symptoms or any of the following
reactions develop during treatment, stop use and see
a doctor immediately: nausea, vomiting, sudden
abdominal pain or long-term abdominal pain with
the loss of appetite and/or jaundice and/or new onset
of itching, diarrhea, heartburn, bloating or
constipation, fluid retention, skin rash or itching,
dizziness, any change in vision, ringing or buzzing
in the ears, vomiting blood, tarry stools, jaundice
(yellowing of the eyes or skin due to liver
problems).
If you experience dizziness, blurred vision, or
hearing problems while taking MOTRIN®, please
use caution when carrying out activities requiring
alertness.
Ibuprofen may cause a severe allergic reaction that
could include wheezing, facial swelling, hives,
shortness of breath, shock or a fast, irregular
heartbeat. Any of these reactions could be serious.
Stop using the product and get emergency medical
help immediately.
This is not a complete list of side effects. For any
unexpected effects while taking MOTRIN®,
contact your doctor or pharmacist.
How to store
Store at 15 to 30°C.
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
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
Questions? 1 888 6MOTRIN / 1 888 666-8746
Last revised: June 18, 2020
© J&J Inc. 2020