Patient Medication Information: uses, side effects, how to take - Children's Motrin Chewable Tablet 50mg
ABOUT THIS MEDICATION
What the medication is used for:
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:
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:
You should not use Children’s MOTRIN* Suspension if:
- your child is taking ibuprofen, acetylsalicylic acid (ASA) or other pain or fever medication
your child is oversensitive to one of the ingredients (symptoms include
facial or throat swelling, shortness of breath, low blood pressure)
- your child has peptic ulcers or gastrointestinal bleeding (bleeding in the urine or stool)
your child has Systemic lupus
Erythmatosus
- your child is suffering from dehydration caused by diarrhea, vomiting or lack of fluid
- you are pregnant or nursing
WARNINGS AND PRECAUTIONS
BEFORE giving Children’s MOTRIN* Suspension 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
- your child is suffering from stomach pain
- your child has peptic ulcers, high blood pressure, heart failure, serious kidney or liver disease, asthma, or is under a doctor's care for any other serious condition or are taking any other drug.
- your child has a history of gastrointestinal disease, blood clotting problems or taking an anticoagulant
Also, see to your doctor if:
- your child does not get any relief within 24 hours.
- redness or swelling is present in the painful area
- a 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)
- any new symptoms appear
INTERACTIONS WITH THIS MEDICATION
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
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 | ||
| lbs. | kg | Years | mL | tsp |
| Under 24 | Under 11 | Under 2 | Use Infant’s MOTRIN* Suspension Drops | |
| 24-35 | 11-15.9 | 2-3 | 5 | 1 |
| 36-47 | 16-21.9 | 4-5 | 7.5 | 1 ½ |
| 48-59 | 22-26.9 | 6-8 | 10 | 2 |
| 60-71 | 27-31.9 | 9-10 | 12.5 | 2 ½ |
| 72-95 | 32-43.9 | 11 | 15 | 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. While uncommon, if stomach upset occurs, Children’s MOTRIN* Suspension can be given with food or milk. If stomach upset persists, talk to your doctor.
Pregnant and nursing women should talk to a doctor before taking any MOTRIN* product.
Adults & children 12 years of age and older: MOTRIN* IB brand is available in tablets, caplets or gelcaps. The equivalent adult dosage of Children’s MOTRIN* Suspension is 200-400 mg (2-4 teaspoons or 10-20 mL) every 4 to 6 hours as needed, not to exceed 1200 mg (12 teaspoons or 60 mL) per day.
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
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, abdominal pain or cramps, 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 | In all cases | ||
| Common | Dizziness | T | |
| 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 | T T T | T T T T T T T |
This is not a complete list of side effects. For any unexpected side effects while taking Children’s MOTRIN* Suspension, talk to your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature, 15°C - 30°C (59°F to 86°F).
Keep this and all medication out of the reach of children.
Child resistant package.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
Product Monograph available to doctors, dentists and pharmacists.
? Contact McNeil Customer Healthcare at: 1-888-6MOTRIN (1-888-666-8746)
Last revised: October 4, 2005
PART III: CONSUMER
INFORMATION
Infants’ MOTRIN* Suspension Drops
(Ibuprofen Oral Suspension McNEIL Std., 40 mg/mL) Pain Reliever / Fever Reducer Up to 8 hour relief of fever.
Only selected information is contained on the bottle label. This information is a summary and will not tell you everything about Infants’ MOTRIN* Suspension Drops. Contact your doctor or pharmacist if you have any questions about the drug.
ABOUT THIS MEDICATION
What the medication is used for:
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:
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:
You should not use Infants’ MOTRIN* Suspension Drops if:
- your child is taking ibuprofen, acetylsalicylic acid (ASA) or other pain or fever medication
your child is oversensitive to one of the ingredients (symptoms include
facial or throat swelling, shortness of breath, low blood pressure)
- your child has peptic ulcers or gastrointestinal bleeding (bleeding in the urine or stool)
your child has Systemic lupus
Erythmatosus
- your child is suffering from dehydration caused by diarrhea, vomiting or lack of fluid
- you are pregnant or nursing
WARNINGS AND PRECAUTIONS
BEFORE giving Infant’s MOTRIN* Suspension Drops 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
- your child is suffering from stomach pain
- your child has asthma, or is under a doctor’s care for any other serious condition or is taking any other drug
- your child has a history of gastrointestinal disease, blood clotting problems, or taking an anticoagulant.
Also, see to your doctor if:
- your child does not get any relief within 24 hours.
- redness or swelling is present in the painful area
- a 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)
- any new symptoms appear
INTERACTIONS WITH THIS MEDICATION
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 | ||||
Usual dose:
Shake suspension well before use.
Infant’s MOTRIN* concentrated drops are not the same concentration as Children’s MOTRIN* Suspension. 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 | |
| lbs. | 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. While uncommon, if stomach upset occurs, Infant’s MOTRIN* Suspension Drops 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
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, abdominal pain or cramps, diarrhea or constipation, heartburn, bloating, fluid retention, indigestion, headache, decreased appetitie.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | |||
| Only if severe | In all cases | |||
| Common | Dizziness | T | ||
| 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 | T T T | T T T T T T T | |
This is not a complete list of side effects. For any unexpected side effects while taking Infants’ MOTRIN* Suspension Drops, talk to your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature, 15°C - 30°C (59°F to 86°F).
Keep this and all medication out of the reach of children.
Child resistant package.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
Product Monograph available to doctors, dentists and pharmacists.
? Contact McNeil Customer Healthcare at: 1-888-6MOTRIN (1-888-666-8746)
Last revised: October 4, 2005
PART III: CONSUMER
INFORMATION
Children’s MOTRIN* Chewable
Tablets
(Ibuprofen Tablets McNEIL Std.,
50 mg)
Pain Reliever / Fever Reducer Up to 8 hour relief of fever.
Only selected information is contained on the package label. This information is a summary and will not tell you everything about Children’s MOTRIN* Chewable Tablets. Contact your doctor or pharmacist if you have any questions about the drug.
ABOUT THIS MEDICATION
What the medication is used for:
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:
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:
You should not use Children’s MOTRIN* Chewable Tablets if:
your child is taking ibuprofen, acetylsalicylic acid (ASA) or other pain or fever medication
- your child is oversensitive to one of the ingredients (symptoms include facial or throat swelling, shortness of breath, low blood pressure)
- your child has peptic ulcers or gastrointestinal bleeding (bleeding in the urine or stool)
your child has Systemic lupus
Erythmatosus
- your child is suffering from dehydration caused by diarrhea, vomiting or lack of fluid
- you are pregnant or nursing
WARNINGS AND PRECAUTIONS
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
- your child is suffering from stomach pain
- your child has peptic ulcers, high blood pressure, heart failure, serious kidney or liver disease, asthma, is under a doctor’s care for any serious condition or is taking any other drug
- your child has a history of gastrointestinal disease, blood clotting problems or taking an anticoagulant
Also, see to your doctor if:
- your child does not get any relief within 24 hours.
- redness or swelling is present in the painful area
- a 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)
- any new symptoms appear
Caution Phenylketonurics: contains phenylalanine (aspartame)
INTERACTIONS WITH THIS MEDICATION
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
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 | |
| lbs. | 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. 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.
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:
skin rash or itching, dizziness, any change in vision,
ringing or buzzing in the ears, nausea or vomiting, abdominal pain or cramps, 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 | In all cases | ||
| Common | Dizziness | T | |
| 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 | T T T | T T T T T T T |
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.
HOW TO STORE IT
Store at room temperature, 15°C - 30°C (59°F to 86°F).
Keep this and all medication out of the reach of children.
Child resistant package.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
Product Monograph available to doctors, dentists and pharmacists.
? Contact McNeil Customer Healthcare at: 1-888-6MOTRIN (1-888-666-8746)
Last revised: October 4, 2005
PART III: CONSUMER
INFORMATION
Junior Strength MOTRIN* Caplets (Ibuprofen Tablets USP, 100 mg)
or
Junior Strength MOTRIN* Chewable
Tablets
(Ibuprofen Tablets McNEIL Std., 100
mg)
Pain Reliever / Fever Reducer Up to 8 hour relief of pain.
Only selected information is contained on the package label. This information is a summary and will not tell you everything about Junior Strength MOTRIN*. Contact your doctor or pharmacist if you have any questions about the drug.
ABOUT THIS MEDICATION
What the medication is used for:
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 is does:
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:
You should not use Junior Strength MOTRIN* if:
- your child is taking ibuprofen, acetylsalicylic acid (ASA) or other pain or fever medication
- your child is oversensitive to one of the ingredients (symptoms include facial or throat swelling, shortness of breath, low blood pressure)
- your child has peptic ulcers or gastrointestinal bleeding (bleeding in the urine or stool)
your child has Systemic lupus
Erythmatosus
- your child is suffering from dehydration caused by diarrhea, vomiting or lack of fluid
- you are pregnant or nursing
WARNINGS AND PRECAUTIONS
BEFORE giving Junior Strength 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
- your child is suffering from stomach pain
- your child has peptic ulcers, high blood pressure, heart failure, serious kidney or liver disease, asthma, is under a doctor’s care for any serious condition or is taking any other drug
- your child has a history of gastrointestinal disease, blood clotting problems or taking anticoagulants
Also, see to your doctor if:
- your child does not get any relief within 24 hours.
- redness or swelling is present in the painful area
- a 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)
- any new symptoms appear Caution Phenylketonurics (Chewable Tablets Only): contains phenylalanine (aspartame).
INTERACTIONS WITH THIS MEDICATION
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
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 | |
| lbs. | kg | Years | Tablets/Caplets |
| 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. While uncommon, if stomach upset occurs, Junior Strength MOTRIN* Tablets/Caplets 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
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, abdominal pain or cramps, 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 | In all cases | ||
| Common | Dizziness | T | |
| 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 | T T T | T T T T T T T |
This is not a complete list of side effects. For any unexpected side effects while taking Junior Strength MOTRIN*, talk to your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature, 15°C - 30°C (59°F to 86°F).
Keep this and all medication out of the reach of children.
Child resistant package.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
Product Monograph available to doctors, dentists and pharmacists.
? Contact McNeil Customer Healthcare at: 1-888-6MOTRIN (1-888-666-8746)