Details for: INFANTS' MOTRIN
Company: MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02238626 | INFANTS' MOTRIN | IBUPROFEN | 40 MG / ML | DROPS | ORAL |
Summary Reports
Summary Safety Review - Ibuprofen- Assessing the Potential Risk of Serious Infection of the Deep Layers of the Skin (Necrotising Fasciitis) in Children with Chickenpox Infection
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
Children’s MOTRIN®
The effective, temporary relief of: Fever and temporary relief of minor aches and pains due to:
- Sore throat
- Earache
- Colds & Flu
- Headache
- Toothache
- Immunization
- Body aches, sprains and strains
Infants’ MOTRIN®
The effective, temporary relief of: Fever and temporary relief of minor aches and pains due to:
- Earache
- Colds & Flu
- Headache
- Teething pain
- Immunization
- Body aches, sprains and strains
Children’s MOTRIN® Chewable Tablets
The effective, temporary relief of: Fever and temporary relief of the minor aches and pains due to:
- Sore throat
- Earache
- Colds & Flu
- Headache
- Toothache
- Immunization
- Body aches, sprains and strains
Junior Strength MOTRIN® Chewable Tablets
The effective, temporary relief of: Fever and temporary relief of the minor aches and pains due to:
- Sore throat
- Earache
- Colds & Flu
- Headache
- Toothache
- Immunization
- Body aches, sprains and strains
What it does
Children’s MOTRIN®
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.
Infants’ MOTRIN®
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.
Children's MOTRIN® Chewable Tablets
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.
Junior Strength MOTRIN® Chewable Tablets
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
Children’s MOTRIN®
Children’s MOTRIN® should not be used:
- if your child is taking ibuprofen, acetylsalicylic acid (ASA) or other pain or fever medication
- if your child is allergic to any of the ingredients in the product (symptoms include facial or throat swelling, shortness of breath, low blood pressure)
- if your child has peptic ulcers or gastrointestinal bleeding (bleeding in the urine or stool, or black stools)
- if your child has Systemic Lupus Erythematosus
- if your child is suffering from dehydration caused by diarrhea, vomiting or lack of fluid
- right before or after heart surgery
- in adults
Infants’ MOTRIN®
Infants’ MOTRIN® should not be used:
- if your child is taking ibuprofen, acetylsalicylic acid (ASA) or other pain or fever medication
- if your child is allergic to any of the ingredients in this product (symptoms include facial or throat swelling, shortness of breath, low blood pressure)
- if your child has peptic ulcers or gastrointestinal bleeding (bleeding in the urine or stool, or black stools)
- if your child has Systemic Lupus Erythematosus
- if your child is suffering from dehydration caused by diarrhea, vomiting or lack of fluid
- right before or after heart surgery
Children's MOTRIN® Chewable Tablets
Children’s MOTRIN® Chewable Tablets should not be used:
- if your child is taking ibuprofen, acetylsalicylic acid (ASA) or other pain or fever medication
- if your child is allergic to any of the ingredients in the product (symptoms include facial or throat swelling, shortness of breath, low blood pressure)
- if your child has peptic ulcers or gastrointestinal bleeding (bleeding in the urine or stool)
- if your child has Systemic Lupus Erythematosus
- if your child is suffering from dehydration caused by diarrhea, vomiting or lack of fluid
- if you are pregnant or nursing
- right before or after heart surgery
Junior Strength MOTRIN® Chewable Tablets
Junior Strength MOTRIN® Chewable Tablets should not be used:
- if your child is taking ibuprofen, acetylsalicylic acid (ASA) or other pain or fever medication
- if your child is allergic to any of the ingredients in the product (symptoms include facial or throat swelling, shortness of breath, low blood pressure)
- if your child has peptic ulcers or gastrointestinal bleeding (bleeding in the urine or stool)
- if your child has Systemic Lupus Erythematosus
- if your child is suffering from dehydration caused by diarrhea, vomiting or lack of fluid
- you are pregnant or nursing
- right before or after heart surgery
What the medicinal ingredient is
Children’s MOTRIN®
Ibuprofen
Infants’ MOTRIN®
Ibuprofen
Children's MOTRIN® Chewable Tablets
Junior Strength MOTRIN® Chewable Tablets
What the non-medicinal ingredients are
Children’s MOTRIN®
See Inactive ingredients section of outer product carton
Infants’ MOTRIN®
See Inactive ingredients section of outer product carton
Children's MOTRIN® Chewable Tablets
Junior Strength MOTRIN® Chewable Tablets
What dosage form it comes in
Children’s MOTRIN®
Oral suspension, 100 mg/5 mL
Infants’ MOTRIN®
Oral suspension, 40 mg/mL
Children's MOTRIN® Chewable Tablets
Junior Strength MOTRIN® Chewable Tablets
Warnings and precautions
Children’s MOTRIN®
BEFORE giving Children’s MOTRIN® to your child, talk to your doctor or pharmacist if your child:
- is dehydrated (significant fluid loss) due to continued vomiting, diarrhea or lack of fluid intake
- is suffering from stomach pain
- has peptic ulcers, high blood pressure, heart failure, serious kidney or liver disease, asthma, diabetes, or is under a doctor's care for any other serious condition or are taking any other drug
- has a history of gastrointestinal disease, blood clotting problems, or taking an anticoagulant
Also, see your doctor if:
- your child does not get any relief within 24 hours
- redness or swelling is present in the painful area
- your child’s sore throat is severe, lasts for more than 2 days or occurs with fever, headache, rash, nausea or vomiting
- your child develops any vision problems (blurred or reduced vision, colour changes occur)
- any new symptoms occur
Long-term continuous use may increase the risk of heart attack or stroke.
Infants’ MOTRIN®
BEFORE giving Infants’ MOTRIN® to your child, talk to your doctor or pharmacist if your child:
- is dehydrated (significant fluid loss) due to continued vomiting, diarrhea or lack of fluid intake
- is suffering from stomach pain
- has peptic ulcers, high blood pressure, heart failure, serious kidney or liver disease, asthma, diabetes, or is under a doctor's care for any other serious condition or are taking any other drug
- has a history of gastrointestinal disease, blood clotting problems, or taking an anticoagulant
Also, see your doctor if:
- your child does not get any relief within 24 hours
- redness or swelling is present in the painful area
- your child’s sore throat is severe, lasts for more than 2 days or occurs with fever, headache, rash, nausea or vomiting
- your child develops any vision problems (blurred or reduced vision, colour changes occur)
- any new symptoms occur
Long-term continuous use may increase the risk of heart attack or stroke.
Children's MOTRIN® Chewable Tablets
BEFORE giving Children’s MOTRIN® Chewable Tablets to your child, talk to your doctor or pharmacist if your child:
- is dehydrated (significant fluid loss) due to continued vomiting, diarrhea or lack of fluid intake
- is suffering from stomach pain
- has peptic ulcers, high blood pressure, heart failure, serious kidney or liver disease, asthma, is under a doctor's care for any other serious condition or is taking any other drug
- has a history of gastrointestinal disease, blood clotting problems, or taking an anticoagulant
Also, see your doctor if:
- your child does not get any relief within 24 hours
- redness or swelling is present in the painful area
- your child’s sore throat is severe, lasts for more than 2 days or occurs with fever, headache, rash, nausea or vomiting
- your child develops any vision problems (blurred or reduced vision, colour changes occur)
- any new symptoms occur
Caution: Phenylketonurics: contains phenylalanine (aspartame)
Junior Strength MOTRIN® Chewable Tablets
BEFORE giving Junior Strength MOTRIN® Chewable Tablets to your child, talk to your doctor or pharmacist if your child:
- is dehydrated (significant fluid loss) due to continued vomiting, diarrhea or lack of fluid intake
- is suffering from stomach pain
- has peptic ulcers, high blood pressure, heart failure, serious kidney or liver disease, asthma, is under a doctor's care for any other serious condition or is taking any other drug
- has a history of gastrointestinal disease, blood clotting problems or taking an anticoagulant
Also, see your doctor if:
- your child does not get any relief within 24 hours
- redness or swelling is present in the painful area
- your child’s sore throat is severe, lasts for more than 2 days or occurs with fever, headache, rash, nausea or vomiting
- your child develops any vision problems (blurred or reduced vision, colour changes occur)
- any new symptoms occur
Caution Phenylketonurics: contains phenylalanine (aspartame).
Interactions with this medication
Children’s MOTRIN®
Talk to your doctor if your child is taking coumarin-type anticoagulants, diuretics (water tablets), digoxin, methotrexate, phenytoin, lithium salt, as some drug interaction could occur.
Infants’ MOTRIN®
Talk to your doctor if your child is taking coumarin-type anticoagulants, diuretics (water tablets), digoxin, methotrexate, phenytoin, lithium salt, as some drug interaction could occur.
Children's MOTRIN® Chewable Tablets
Talk to your doctor if your child is taking coumarin-type anticoagulants, diuretics (water tablets), digoxin, methotrexate, phenytoin, lithium salt, as some drug interaction could occur.
Junior Strength MOTRIN® Chewable Tablets
Talk to your doctor if your child is taking coumarin-type anticoagulants, diuretics (water tablets), digoxin, methotrexate, phenytoin, lithium salt, as some drug interaction could occur.
Proper use of this medication
Infants’ MOTRIN®
Children's MOTRIN® Chewable Tablets
Junior Strength MOTRIN® Chewable Tablets
Children’s MOTRIN®
Usual dose
Shake suspension well before use. Use only the enclosed measuring
cup or a measured teaspoon to dose this product. Do not use any other
dosing device. Measure dose with the dosage cup provided and ensure
the complete dose is taken.
For accurate dosing, follow the instructions carefully. Find the right
dose on the chart. If possible, use weight to dose, otherwise use age
| Weight | Age | Single Oral Dose | |
|---|---|---|---|
| lb | kg | Years | mL |
| Under 24 | Under 11 | Under 2 | Use Infants’ MOTRIN® |
| 24-35 | 11-15.9 | 2-3 | 5 |
| 36-47 | 16-21.9 | 4-5 | 7.5 |
| 48-59 | 22-26.9 | 6-8 | 10 |
| 60-71 | 27-31.9 | 9-10 | 12.5 |
| 72-95 | 32-43.9 | 11 | 15 |
Single dose may be repeated every 6 to 8 hours as needed. Do not exceed
4 doses of ibuprofen per day unless advised by a doctor.
Do not use for more than 3 days for fever or 5 days for pain unless
directed by a doctor. Use the lowest effective dose for the shortest duration.
While uncommon, if stomach upset occurs, Children’s MOTRIN® can be
given with food or milk. If stomach upset persists, talk to your doctor.
Overdose
In case of accidental overdose, even if there are no symptoms, call a doctor or Poison Control Centre at once.
Infants’ MOTRIN®
Usual dose
Shake suspension well before use. Infants’ MOTRIN® concentrated drops are not the same concentration as Children’s MOTRIN®. Measure dose with oral syringe provided and ensure the complete dose is taken. Oral syringe should be rinsed and dried between uses. Replace child-resistant cap after each use. For accurate dosing, only use the enclosed oral syringe and follow the instructions carefully. If possible, dose according to body weight.
| Weight | Age | Single Oral Dose | |
|---|---|---|---|
| lb | kg | Months | mL |
| Under 12 | Under 5.5 | Under 4 | As directed by a doctor |
| 12-17 | 5.5-7.9 | 4-11 | 1.25 |
| 18-23 | 8-10.9 | 12-23 | 1.875 |
Single dose may be repeated every 6 to 8 hours as needed. Do not exceed
4 doses of ibuprofen per day unless advised by a doctor.
Do not use for more than 3 days for fever or 5 days for pain unless
directed by a doctor. Use the lowest effective dose for the shortest duration.
While uncommon, if stomach upset occurs, Infants’ MOTRIN® can be
given with food or milk. If stomach upset persists, talk to your doctor.
Overdose
In case of accidental overdose, even if there are no symptoms, call a doctor or Poison Control Centre at once.
Children's MOTRIN® Chewable Tablets
Usual dose
For accurate dosing, follow the instructions carefully. Find the right dose on the chart. If possible, use weight to dose, otherwise use age.
| Weight | Age | Single Oral Dose | |
|---|---|---|---|
| lb | kg | Years | Tablets |
| Under 24 | Under 11 | Under 2 | As directed by a doctor |
| 24-35 | 11-15.9 | 2-3 | 2 |
| 36-47 | 16-21.9 | 4-5 | 3 |
| 48-59 | 22-26.9 | 6-8 | 4 |
Single dose may be repeated every 6 to 8 hours as needed. Do not exceed 4
doses of ibuprofen per day unless advised by a doctor.
Do not use for more than 3 days for fever or 5 days for pain unless directed
by a doctor. Use the lowest effective dose for the shortest duration. While
uncommon, if stomach upset occurs, Children’s MOTRIN® Chewable
Tablets can be given with food or milk. If stomach upset persists, talk to
your doctor.
Overdose
In case of accidental overdose, even if there are no symptoms, call a doctor or Poison Control Centre at once.
Junior Strength MOTRIN® Chewable Tablets
Usual dose
For accurate dosing, follow the instructions carefully. Find the right dose on the chart. If possible, use weight to dose, otherwise use age.
| Weight | Age | Single Oral Dose | |
|---|---|---|---|
| lb | kg | Years | Tablets |
| 48-59 | 22-26.9 | 6-8 | 2 |
| 60-71 | 27-31.9 | 9-10 | 2 ½ |
| 72-95 | 32-43.9 | 11 | 3 |
Single dose may be repeated every 6 to 8 hours as needed. Do not exceed 4
doses of ibuprofen per day unless advised by a doctor.
Do not use for more than 3 days for fever or 5 days for pain unless directed
by a doctor. Use the lowest effective dose for the shortest duration. While
uncommon, if stomach upset occurs, Junior Strength MOTRIN® Chewable
Tablets can be given with food or milk. If stomach upset persists, talk to
your doctor.
Overdose
In case of accidental overdose, even if there are no symptoms, call a doctor or Poison Control Centre at once.
Side effects and what to do about them
Infants’ MOTRIN®
Children's MOTRIN® Chewable Tablets
Junior Strength MOTRIN® Chewable Tablets
Children’s MOTRIN®
If unusual symptoms or any of the following reactions develop during treatment, stop use and see a doctor immediately:
- skin rash or itching, dizziness, any change in vision, ringing or buzzing in the ears, nausea or vomiting, sudden abdominal pain or long-term abdominal pain with the loss of appetite and/or jaundice and/or new onset of itching, diarrhea or constipation, heartburn, bloating, fluid retention, indigestion, headache, decreased appetite
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | |
|---|---|---|---|
| Common | |||
| Dizziness | ✔ | ||
| Uncommon | |||
| Blurred/reduced vision | ✔ | ||
| Vision colour changes | ✔ | ||
| Ringing in ears | ✔ | ||
| Blood in urine or stool | ✔ | ||
| Swelling of mouth, throat and extremities | ✔ | ||
| Difficulty breathing | ✔ | ||
| Abdominal pain | ✔ | ||
| Severe skin rash | ✔ | ||
| Weight gain/fluid retention | ✔ | ||
| Bruising | ✔ | ||
This is not a complete list of side effects. For any unexpected side effects while taking Children’s MOTRIN®, talk to your doctor or pharmacist.
Infants’ MOTRIN®
If unusual symptoms or any of the following reactions develop during treatment, stop use and see a doctor immediately:
- skin rash or itching, dizziness, any change in vision, ringing or buzzing in the ears, nausea or vomiting, sudden abdominal pain or long-term abdominal pain with the loss of appetite and/or jaundice and/or new onset of itching, diarrhea or constipation, heartburn, bloating, fluid retention, indigestion, headache, decreased appetite
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | |
|---|---|---|---|
| Dizziness | ✔ | ||
| Uncommon | |||
| Blurred/reduced vision | ✔ | ||
| Vision colour changes | ✔ | ||
| Ringing in ears | ✔ | ||
| Blood in urine or stool | ✔ | ||
| Swelling of mouth, throat and extremities | ✔ | ||
| Difficulty breathing | ✔ | ||
| Abdominal pain | ✔ | ||
| Severe skin rash | ✔ | ||
| Weight gain/fluid retention | ✔ | ||
| Bruising | ✔ | ||
This is not a complete list of side effects. For any unexpected side effects while taking Infants’ MOTRIN®, talk to your doctor or pharmacist.
Children's MOTRIN® Chewable Tablets
If unusual symptoms or any of the following reactions develop during treatment, stop use and see a doctor immediately:
- skin rash or itching, dizziness, any change in vision, ringing or buzzing in the ears, nausea or vomiting, sudden abdominal pain or long-term abdominal pain with the loss of appetite and/or jaundice and/or new onset of itching, diarrhea or constipation, heartburn, bloating, fluid retention, indigestion, headache, decreased appetite
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | |
|---|---|---|---|
| Dizziness | ✔ | ||
| Uncommon | |||
| Blurred/reduced vision | ✔ | ||
| Vision colour changes | ✔ | ||
| Ringing in ears | ✔ | ||
| Blood in urine or stool | ✔ | ||
| Swelling of mouth, throat and extremities | ✔ | ||
| Difficulty breathing | ✔ | ||
| Abdominal pain | ✔ | ||
| Severe skin rash | ✔ | ||
| Weight gain/fluid retention | ✔ | ||
| Bruising | ✔ | ||
This is not a complete list of side effects. For any unexpected side effects while taking Children’s MOTRIN® Chewable Tablets, talk to your doctor or pharmacist.
Junior Strength MOTRIN® Chewable Tablets
If unusual symptoms or any of the following reactions develop during treatment, stop use and see a doctor immediately:
- skin rash or itching, dizziness, any change in vision, ringing or buzzing in the ears, nausea or vomiting, sudden abdominal pain or long-term abdominal pain with the loss of appetite and/or jaundice and/or new onset of itching, diarrhea or constipation, heartburn, bloating, fluid retention, indigestion, headache, decreased appetite
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | |
|---|---|---|---|
| Common | |||
| Dizziness | ✔ | ||
| Uncommon | |||
| Blurred/reduced vision | ✔ | ||
| Vision colour changes | ✔ | ||
| Ringing in ears | ✔ | ||
| Blood in urine or stool | ✔ | ||
| Swelling of mouth, throat and extremities | ✔ | ||
| Difficulty breathing | ✔ | ||
| Abdominal pain | ✔ | ||
| Severe skin rash | ✔ | ||
| Weight gain/fluid retention | ✔ | ||
| Bruising | ✔ | ||
This is not a complete list of side effects. For any unexpected side effects while taking Junior Strength MOTRIN® Chewable Tablets talk to your doctor or pharmacist.
How to store
Children’s MOTRIN®
Store at room temperature, 15°C - 30°C.
Keep this and all medication out of the reach of children.
Child resistant package
Infants’ MOTRIN®
Store at room temperature, 15°C - 30°C.
Keep this and all medication out of the reach of children.
Child resistant package.
Children's MOTRIN® Chewable Tablets
Store at room temperature, 15°C - 30°C.
Keep this and all medication out of the reach of children.
Child resistant package.
Junior Strength MOTRIN® Chewable Tablets
Store at room temperature, 15°C - 30°C.
Keep this and all medication out of the reach of children.
Child resistant package.
Reporting side effects
Children’s MOTRIN®
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.
Infants’ MOTRIN®
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.
Children's MOTRIN® Chewable Tablets
REPORTING SUSPECTED SIDE EFFECTS
You can help improve the safe use of health products for
Canadians by reporting serious and unexpected side effects
to Health Canada. Your report may help to identify new side
effects and change the product safety information.
3 ways to report:
- Online at MedEffect;
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E
Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting
Form are available at MedEffect.
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.
Junior Strength MOTRIN® Chewable Tablets
REPORTING SUSPECTED SIDE EFFECTS
You can help improve the safe use of health products for
Canadians by reporting serious and unexpected side effects
to Health Canada. Your report may help to identify new side
effects and change the product safety information.
3 ways to report:
- Online at MedEffect;
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E
Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting
Form are available at MedEffect.
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
Product monograph available to doctors, dentists and pharmacists.
Questions? Contact McNeil Consumer Healthcare, division of
Johnson & Johnson, Inc. at: 1-888-6MOTRIN (1-888-666-8746)
Last revised: June 18, 2020
© J&J Inc. 2020