Страна: Канада
Язык: английский
Источник: Health Canada
IBUPROFEN
MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
M01AE01
IBUPROFEN
200MG
TABLET
IBUPROFEN 200MG
ORAL
10/24/50/100/150
OTC
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0108883004; AHFS:
APPROVED
2013-02-14
MOTRIN® 200 mg / MOTRIN® 300 mg / MOTRIN® 400 mg (Ibuprofen Tablets USP) _ _ _Page 1 of 41 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION MOTRIN ® 200 MG MOTRIN ® 300 MG MOTRIN ® 400 MG Ibuprofen Tablets Tablets, 200 mg / 300 mg / 400 mg, Oral USP Non-Steroidal Anti-inflammatory Drug Analgesic, Antipyretic Agent McNeil Consumer Healthcare Division of Johnson & Johnson Inc. 88 McNabb Street Markham, Canada L3R 5L2 Date of Initial Authorization: [FEB 14,2013] Date of Revision: April 04, 2023 Submission Control Number: 265403 _ _ MOTRIN® 200 mg / MOTRIN® 300 mg / MOTRIN® 400 mg (Ibuprofen Tablets USP) _ _ _Page 2 of 41_ RECENT MAJOR LABEL CHANGES 3 SERIOUS WARNINGS AND PRECAUTIONS BOX [04/2023] 7 WARNINGS AND PRECAUTIONS Monitoring and Laboratory Tests [04/2023] 7 WARNINGS AND PRECAUTIONS 7.1.1 Pregnant Women [04/2023] TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES ............................................................................................ 2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS ............................................................................................................... 4 1.1 Pediatrics ................................................................................................................ 4 1.2 Geriatrics ................................................................................................................ 4 2 CONTRAINDICATIONS ................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION ................................................................................. Прочитать полный документ