Maa: Kanada
Kieli: englanti
Lähde: Health Canada
IBUPROFEN
MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
M01AE01
IBUPROFEN
200MG
TABLET
IBUPROFEN 200MG
ORAL
100
OTC
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0108883004; AHFS:
CANCELLED PRE MARKET
2016-01-22
PRODUCT MONOGRAPH MOTRIN ® IB Menstrual Pain Ibuprofen Tablets USP, 200 mg Super Strength MOTRIN ® IB Menstrual Pain Ibuprofen Tablets USP, 400 mg Non-Steroidal Anti-inflammatory Drug Analgesic, Antipyretic Agent McNeil Consumer Healthcare Division of Johnson & Johnson Inc. 88 McNabb Street Markham, Canada L3R 5L2 www.motrin.ca Date of Revision: September 20, 2012 CONTROL NUMBER: 156423 _ _ _Page 2 of 37_ 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 ..................................................................................................10 DRUG INTERACTIONS ..................................................................................................13 DOSAGE AND ADMINISTRATION ..............................................................................15 OVERDOSAGE ................................................................................................................16 ACTION AND CLINICAL PHARMACOLOGY ............................................................17 STORAGE AND STABILITY ..........................................................................................18 SPECIAL HANDLING INSTRUCTIONS .......................................................................19 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................19 PART II: SCIENTIFIC INFORMATION ...............................................................................20 PHARMACEUTICAL INFORMATION .................................................................. Lue koko asiakirja