Country: Canada
Language: English
Source: Health Canada
IBUPROFEN
MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
M01AE01
IBUPROFEN
40MG
DROPS
IBUPROFEN 40MG
ORAL
15/30 ML
OTC
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0108883007; AHFS:
APPROVED
1998-09-08
_Children’s MOTRIN_ _®_ _, Ibuprofen Oral Suspension, 100 mg/5 mL _ _Infants’ MOTRIN_ _®_ _, Ibuprofen Oral Suspension, 40 mg/10 mL _ _Children’s/Junior Strength MOTRIN_ _®_ _ Chewable Tablets, Ibuprofen Tablets, 50 mg and 100 mg _ _ _ _Page 1 of 66_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION CHILDREN’S MOTRIN® Ibuprofen Oral Suspension Suspension, 100 mg/5 mL, Oral McNeil Std. Analgesic/Antipyretic INFANTS’ MOTRIN® Ibuprofen Oral Suspension Suspension, 40 mg/10 mL, Oral McNeil Std. Analgesic/Antipyretic CHILDREN’S/JUNIOR STRENGTH MOTRIN® CHEWABLE TABLETS Ibuprofen Tablets Tablet, 50 mg and 100 mg, Oral McNeil Std. Analgesic/Antipyretic McNeil Consumer Healthcare Division of Johnson & Johnson Inc. 88 McNabb Street Markham, Canada L3R 5L2 Date of Initial Authorization: [OCT 14,1998] Date of Revision: March 30, 2023 Submission Control Number: 265393 _ _ _Children’s MOTRIN_ _®_ _, Ibuprofen Oral Suspension, 100 mg/5 mL _ _Infants’ MOTRIN_ _®_ _, Ibuprofen Oral Suspension, 40 mg/10 mL _ _Children’s/Junior Strength MOTRIN_ _®_ _ Chewable Tablets, Ibuprofen Tablets, 50 mg and 100 mg _ _Page 2 of 66_ RECENT MAJOR LABEL CHANGES 3 SERIOUS WARNINGS AND PRECAUTIONS BOX [03/2023] 7 WARNINGS AND PRECAUTIONS Monitoring and Laboratory Tests [03/2023] 7 WARNINGS AND PRECAUTIONS 7.1.1 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 1.1 Pediatrics ....................................................................... Read the complete document