Страна: Канада
Язык: английский
Источник: Health Canada
IBUPROFEN
MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
M01AE01
IBUPROFEN
50MG
TABLET (CHEWABLE)
IBUPROFEN 50MG
ORAL
24
OTC
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0108883009; AHFS:
APPROVED
2003-04-09
PRODUCT MONOGRAPH Children’s MOTRIN ® (Ibuprofen Oral Suspension McNeil Std., 100 mg/5 mL ) Infants’ MOTRIN ® (Ibuprofen Oral Suspension McNeil Std., 40 mg/mL) Children’s/Junior Strength MOTRIN ® Chewable Tablets (Ibuprofen Tablets McNeil Std., 50 mg and 100 m g) Analgesic/Antipyretic McNeil Consumer Healthcare Division of Johnson & Johnson Inc. 88 McNabb Street Markham, Ontario L3R 5L2 Submission Control #: 237473 Last Approved: February 26, 2015 Date of Revision: June 18, 2020 Children’s Motrin ® / Infants’ MOTRIN ® Page 2 of 43 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION ........................................................................... 3 SUMMARY PRODUCT INFORMATION .............................................................................................. 3 INDICATIONS AND CLINICAL USE ................................................................................................. 3 CONTRAINDICATIONS ........................................................................................................................ 3 WARNINGS AND PRECAUTIONS ........................................................................................................ 4 ADVERSE REACTIONS ......................................................................................................................... 8 DRUG INT E RACTIONS ....................................................................................................................... 10 DOSAGE AND ADM INISTRATION .................................................................................................. 12 OVERDOSAGE ....................................................................................................................................... 13 ACTION AND CLINICAL PHARMACOLOGY ................................................................................. 14 STORAGE AND STABILITY ............................................................................................................... 16 SPECIAL HANDLI Прочитать полный документ