INFANTS' MOTRIN

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 Children’s MOTRIN® 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 Children’s MOTRIN®, subsequent doses may be lowered and still provide adequate fever control. In a situation when lower fever would require the Children’s MOTRIN® 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. Children’s MOTRIN®, Ibuprofen Oral Suspension, 100 mg/5 mL Infants’ MOTRIN®, Ibuprofen Oral Suspension, 40 mg/mL Children’s/Junior Strength MOTRIN® Chewable Tablets, Ibuprofen Tablets, 50 mg and 100 mg Page 7 of 66 Unclassified / Non classifié Children: Children’s MOTRIN® (Ibuprofen) Age Weight Single Dose1 lbs.

9 15 mL = 300 mg 6 tablets = 300 mg 3 tablets = 300 mg 1 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. * Only Infants’ MOTRIN® (suspension drops) are labelled for children under 2 years of age.

Consumer labelling for Children’s MOTRIN® (suspension) 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. ** Infants’ MOTRIN® (suspension drops) 40 mg/mL are labelled “as directed by a doctor” for children under 4mo.

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 [03/2023] TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................

1 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................

2 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................

4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION ................................................................................. 8 5 OVERDOSAGE..............................................................................................................

8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 9 7 WARNINGS AND PRECAUTIONS ................................................................................ 19 8 ADVERSE REACTIONS ................................................................................................

1 Clinical trial adverse reactions: Pediatrics…………………......................................... 29 10 CLINICAL PHARMACOLOGY ....................................................................................... 31 11 STORAGE, STABILITY AND DISPOSAL .........................................................................

33 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 33 PART II: SCIENTIFIC INFORMATION .......................................................................................

Children’s MOTRIN® (ibuprofen) should not be used in patients: • with active peptic ulcer or gastrointestinal bleeding, or with a history of recurrent ulceration or active inflammatory disease of the gastrointestinal system. • who have previously exhibited hypersensitivity to it or to any ingredient in the formulation.

For a complete listing of ingredients, see 6 Dosage Forms, Strengths, Composition and Packaging. The potential for cross-reactivity between different nonsteroidal anti- inflammatory drugs (NSAIDs) must be kept in mind. • with the complete or partial syndrome of nasal polyps, or in whom asthma, anaphylaxis, urticarial/angioedema, rhinitis or other allergic manifestations are precipitated by ASA or other nonsteroidal anti-inflammatory agents.

Fatal anaphylactoid reactions have occurred in such individuals. As well, individuals with the above medical problems are at risk of a Children’s MOTRIN®, Ibuprofen Oral Suspension, 100 mg/5 mL Infants’ MOTRIN®, Ibuprofen Oral Suspension, 40 mg/mL Children’s/Junior Strength MOTRIN® Chewable Tablets, Ibuprofen Tablets, 50 mg and 100 mg Page 5 of 66 Unclassified / Non classifié severe reaction even if they have taken NSAIDs in the past without any adverse effects.

• during the third trimester of pregnancy, because of risk of premature closure of the ductus arteriosus and prolonged parturition. • with Systemic Lupus Erythematosus as an anaphylaxis like reaction with fever may occur, particularly when ibuprofen has been administered previously.

Aseptic meningitis has also been reported. • With significant hepatic impairment or active liver disease. • With kidney disease or severely impaired or deteriorating renal function (creatinine clearance <30 mL/min). Individuals with lesser degrees of renal impairment are at risk of deterioration of their renal function when prescribed NSAIDs and must be monitored.