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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
02238626INFANTS' MOTRINIBUPROFEN40 MG / MLDROPSORAL
Search Reported Side Effects Report a Side Effect

Summary Reports

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

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:

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

Date modified: