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IBUPROFEN is a brand name for Ibuprofen, supplied as a suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: IBUPROFEN ORAL SUSPENSION USP (Ibuprofen Oral Suspension USP) is indicated for temporary relief of: • minor aches and pains in muscles, bones and joints • headache • fever • the aches and fever due to the common cold or flu, immunizations, toothache (dental pain), sore throat, earache. 1.1 Pediatrics Pediatrics (<12…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations 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.
2 Recommended Dose and Dosage Adjustment Prescribed Dosage and Administration: • Fever Reduction: For reduction of fever in children up to 12 years of age, the dosage should be adjusted on the basis of the initial temperature level.
1°C) or greater. The duration of fever reduction is generally 6 to 8 hours. The recommended maximum daily dose is 40 mg/kg. • Analgesia: For relief of mild to moderate pain in children up to 12 years of age, the recommended dosage is 10 mg/kg, every 6 to 8 hours.
The recommended maximum daily dose is 40 mg/kg. Doses should be given so as not to disturb the child’s sleep pattern. • Individualization of Dosage: The dose of IBUPROFEN ORAL SUSPENSION USP should be tailored to each patient and may be lowered or raised from the suggested doses depending on the severity of symptoms either at the time of initiating drug therapy or as the patient responds or fails to respond.
• Limited data suggests that, after the initial dose of IBUPROFEN ORAL SUSPENSION USP, subsequent doses may be lowered and still provide adequate fever control. In a situation when lower fever would require the IBUPROFEN ORAL SUSPENSION USP 5 mg/kg dose in a child with pain, the dose that will effectively treat the predominant symptom should be chosen.
5 mg/kg for either pain or fever. • Do not use in adults. Table 1 Age Weight Single Dose1 lbs. 5 mL = 50 mg IBUPROFEN ORAL SUSPENSION USP (Ibuprofen Oral Suspension USP) Page 7 of 48 Age Weight Single Dose1 lbs. 9 15 mL = 300 mg 1Single dose may be given every 6 to 8 hours as needed but do not exceed 4 doses per day unless advised by your doctor.
*Consumer labeling for IBUPROFEN ORAL SUSPENSION USP 100 mg/5 mL does not offer dosing for children under 2 years of age; therefore, these doses are provided as a guide for professional recommendations to consumers. 4 Administration Take with food or milk if mild upset stomach occurs with use.
5 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 your missed dose. Do not take two doses at the same time.
1 Adverse Reaction Overview Experience reported with prescription use of ibuprofen has included the adverse reactions listed in this section.
Note:
Reactions listed under Causal Relationship Unknown are those where a causal relationship could not be established; however, in these rarely reported events, the possibility of a relationship to ibuprofen also cannot be excluded. The adverse reactions most frequently seen with ibuprofen therapy involve the gastrointestinal system.
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. 1 Clinical Trial Adverse Reactions: Pediatrics Safety studies of ibuprofen suspension in children are among the largest prospective clinical trials ever conducted.
Both the Children’s Analgesic Medicine Project (CAMP) and the Boston Fever Study enrolled a wide age range of children, which supports the generalisability of these studies’ findings. These large-scale studies focused on examining the potential risk in children of several rare events that can be related to the pharmacologic action of NSAIDs: GI bleeding, acute renal failure, and anaphylaxis.
The Children’s Analgesic Medicine Project (CAMP) was a multicenter, all-comers, open-label, prospective study to compare the safety of ibuprofen suspension with acetaminophen suspension in children with fever and/or pain. Four hundred twenty four (424) paediatricians enrolled 41,810 children (aged 1 month to 18 years old) at 69 US clinics.
1 Pregnant Women 09/2025 TABLE OF CONTENTS Certain sections or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS ............................................................................................................ 1 Pediatrics...............................................................................................................
2 Geriatrics ............................................................................................................... 4 2 CONTRAINDICATIONS...............................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .......................................................... 5 4 DOSAGE AND ADMINISTRATION............................................................................... 1 Dosing Considerations ..........................................................................................
2 Recommended Dose and Dosage Adjustment ..................................................... 4 Administration ...................................................................................................... 5 Missed Dose ..........................................................................................................
7 5 OVERDOSAGE........................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 9 7 WARNINGS AND PRECAUTIONS ..............................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Safety data included information concerning medication use and adverse events summarised by severity and analysed by age groups (younger and older than 2 years). Among 30,238 children who took at least one dose of ibuprofen or acetaminophen, 14,281 were younger (< 12 years) and 15,863 were older (2 to < 12 years).
Within both age groups, the incidence rates for specific AEs, including abdominal pain, insomnia, and hyperkinesia were rare and generally 1% (in either treatment group). For older children, the only AEs with an incidence rate >1% in either group were rhinitis, pharyngitis and otitis media.
AEs were generally mild to moderate for both treatments within the two age groups. There were no serious AEs, including anaphylaxis, Reye’s syndrome, renal failure, GI bleeding/perforation or necrotizing fasciitis. Overall, ibuprofen exhibited an AE profile similar to acetaminophen in both younger and older children.
IBUPROFEN ORAL SUSPENSION USP (Ibuprofen Oral Suspension USP) Page 21 of 48 The Boston Fever Study was a large, randomized, double-blind study that assessed the risk of rare but serious adverse events following the use of ibuprofen suspension in febrile children between the ages of 6 months and 12 years of age.
S. Children were randomized to receive ibuprofen suspension 5 mg/kg (N=27,948), ibuprofen suspension 10 mg/kg (N=27,837) or acetaminophen suspension 12 mg/kg (N=28,130). Medications were given every 4 to 6 hours, as needed, up to five doses per day.
The study focused on hospitalisations for acute GI bleeding, acute renal failure, and anaphylaxis, as well as monitoring for the occurrence of Reye syndrome. In the entire pediatric population, the authors found no significant difference between ibuprofen- and acetaminophen-treated children in the observed risk of GI bleeding, acute renal failure, or anaphylaxis.
No cases of Reye syndrome were seen in febrile children. The safety findings of the Boston Fever Study are concordant with those of the Children’s Analgesic Medicine Project: ibuprofen is well tolerated in children at doses of 20 to 30 mg/kg/day and higher.
No symptom or syndrome emerged in these trials that was not predictable from the drug’s pharmacology or could not be anticipated based on ibuprofen’s extensive use as an analgesic/antipyretic in adults. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Gastrointestinal: The generally modest elevations of serum transaminase activity that has been observed are usually without clinical sequelae but severe, potentially fatal toxic hepatitis can occur.
Renal:
Renal blood flow glomerular filtration rate decreased in patients with mild impairment of renal functions who took 1200 mg/day of ibuprofen for one week. Renal papillary necrosis has been reported. A number of factors appear to increase the risk of renal toxicity.
5 Post-Market Adverse Reactions The following adverse reactions have been noted in patients treated with prescription doses (≥1200 mg/day).
Note:
Reactions listed below under Causal Relationship Unknown are those which occurred under circumstances where a causal relationship could not be established. However, in these rarely reported events, the possibility of a relationship to ibuprofen cannot be excluded.
Gastrointestinal IBUPROFEN ORAL SUSPENSION USP (Ibuprofen Oral Suspension USP) Page 22 of 48 The adverse reactions most frequently seen with prescribed ibuprofen therapy involve the gastrointestinal system. Incidence 3 to 9%: nausea, epigastric pain, heartburn Incidence 1 to 3%: diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of the gastrointestinal tract (bloating or flatulence).
Incidence less than 1%: gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal haemorrhage, melena, hepatitis, jaundice, abnormal liver function (SGOT, serum bilirubin and alkaline phosphatase), pancreatitis, oral discomfort (local burning, sensation, irritation).
Allergic […]
1 Special Populations ............................................................................................. 1 Pregnant Women ................................................................................................ 2 Breast-feeding .....................................................................................................
4 Geriatrics ............................................................................................................. 19 8 ADVERSE REACTIONS .............................................................................................
1 Adverse Reaction Overview ................................................................................ 2 Clinical Trial Adverse Reactions .......................................................................... 1 Clinical trial adverse reactions: Pediatrics ..........................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data................................................................................................ 5 Post-Market Adverse Reactions..........................................................................
21 9 DRUG INTERACTIONS ............................................................................................. 1 Serious Drug Interactions ................................................................................... 2 Drug Interactions Overview ................................................................................
4 Drug-Drug Interactions ....................................................................................... 5 Drug-Food Interactions ....................................................................................... 6 Drug-Herb Interactions .......................................................................................
7 Drug-Laboratory Test Interactions...................................................................... 29 10 CLINICAL PHARMACOLOGY ..................................................................................... 1 Mechanism of Action ..........................................................................................
2 Pharmacodynamics ............................................................................................. 3 Pharmacokinetics ................................................................................................ 31 11 STORAGE, STABILITY AND DISPOSAL .......................................................................
32 12 SPECIAL HANDLING INSTRUCTIONS......................................................................... 33 PART II: SCIENTIFIC INFORMATION ...................................................................................... 34 13 PHARMACEUTICAL INFORMATION .........................................................................
34 14 CLINICAL TRIALS ..................................................................................................... 1 Trial Design and Study Demographics ................................................................ 2 Study Results .......................................................................................................
3 Comparative Bioavailability Studies ................................................................... 37 15 MICROBIOLOGY ..................................................................................................... 37 16 NON-CLINICAL TOXICOLOGY ...................................................................................
37 17 SUPPORTING PRODUCT MONOGRAPHS […]