国家: 加拿大
语言: 英文
来源: Health Canada
ACETAMINOPHEN; CODEINE PHOSPHATE
JANSSEN INC
N02AJ06
CODEINE AND PARACETAMOL
300MG; 60MG
TABLET
ACETAMINOPHEN 300MG; CODEINE PHOSPHATE 60MG
ORAL
100
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0211376001; AHFS:
CANCELLED POST MARKET
2020-09-25
_~db5_O57037c1db3eb487b8c40bf219e186e85.docx _ _ _ _EDMS-RIM-569211 v2.0 _ _ _ _Page 1 of 38 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION N TYLENOL ® WITH CODEINE NO. 4 300 mg acetaminophen and 60 mg codeine phosphate tablets acetaminophen and codeine phosphate tablets, USP Analgesic-Antipyretic Janssen Inc. 200 Whitehall Drive Markham, Ontario L3R 0T5 www.janssen.com/canada Date of Revision: December 7, 2021 SUBMISSION CONTROL NO: 258440 All trademarks used under license. © 2021 Janssen Inc. _~db5_O57037c1db3eb487b8c40bf219e186e85.docx _ _ _ _EDMS-RIM-569211 v2.0 _ _ _ _Page 2 of 38 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................5 ADVERSE REACTIONS ..................................................................................................15 DRUG INTERACTIONS ..................................................................................................16 DOSAGE AND ADMINISTRATION ..............................................................................18 OVERDOSAGE ................................................................................................................20 ACTION AND CLINICAL PHARMACOLOGY ............................................................23 STORAGE AND STABILITY ..........................................................................................25 SPECIAL HANDLING INSTRUCTIONS .......................................................................25 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................25 PART II 阅读完整的文件