Details for: CHILDREN'S IBUPROFEN SUSPENSION
Company: PERRIGO INTERNATIONAL
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02280175 | CHILDREN'S IBUPROFEN SUSPENSION | IBUPROFEN | 100 MG / 5 ML | SUSPENSION | 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
The effective, temporarily 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
What it does
Ibuprofen is a member of a class of drugs called nonsteroidal antiinflammatory 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 IBUPROFEN Suspension 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.
What the medicinal ingredient is
Ibuprofen
What the non-medicinal ingredients are
See Inactive ingredients section of outer product carton.
What dosage form it comes in
Oral suspension, 100 mg/5 mL
Warnings and precautions
BEFORE you use Children’s IBUPROFEN Suspension, 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.
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 interactions could occur.
Proper use of this medication
Usual Dose
Shake suspension well before use. Use only the enclosed dosage cup. 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 Dose† | |
| (lbs) | (kg) | (years) | (mL) |
| Under 24 | Under 11 | Under 2 | As directed by a doctor |
| 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 given every 6 to 8 hours as needed but do not exceed 4 doses per day unless advised by your doctor.
Do not take for fever for more than 3 days or pain for more than 5 days unless directed by a physician. Use the lowest effective dose for the shortest duration. If the painful area is red or swollen, if condition deteriorates or new symptoms occur, consult a physician.
Overdose
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
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.
| 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 effects while taking Children’s IBUPROFEN Suspension, contact your doctor or pharmacist.
How to store
Store at controlled room temperature (15-30°C).
Protect from high humidity and excessive heat.
Keep out of the reach of children.
Child-resistant package.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa, Ontario
K1A 0K9
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Perrigo International, at: 1-800-719-9260
This leaflet was prepared by Perrigo International.
Last revised: Jul 20, 2020.