TYLENOL WITH CODEINE NO. 3 - TAB TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
17-09-2020
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Aktiv bestanddel:
ACETAMINOPHEN; CODEINE PHOSPHATE; CAFFEINE
Tilgængelig fra:
JANSSEN INC
ATC-kode:
N02AJ06
INN (International Name):
CODEINE AND PARACETAMOL
Dosering:
300MG; 30MG; 15MG
Lægemiddelform:
TABLET
Sammensætning:
ACETAMINOPHEN 300MG; CODEINE PHOSPHATE 30MG; CAFFEINE 15MG
Indgivelsesvej:
ORAL
Enheder i pakken:
500
Recept type:
Narcotic (CDSA I)
Terapeutisk område:
OPIATE AGONISTS
Produkt oversigt:
Active ingredient group (AIG) number: 0311391005; AHFS:
Autorisation status:
CANCELLED POST MARKET
Autorisation dato:
2020-09-25
Produktets egenskaber
_242770 APM.docx _
_EDMS-RIM-101028v6.0 _
_Page 1 of 39 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
TYLENOL
® WITH CODEINE NO. 2
acetaminophen, caffeine and codeine phosphate tablets
300 mg acetaminophen, 15 mg caffeine and 15 mg codeine phosphate
tablets
N
TYLENOL
® WITH CODEINE NO. 3
acetaminophen, caffeine and codeine phosphate tablets
300 mg acetaminophen, 15 mg caffeine and 30 mg codeine phosphate
tablets
Analgesic-Antipyretic
Janssen Inc.
200 Whitehall Drive
Markham, Ontario
L3R 0T5
www.janssen.com/canada
Date of Revision:
September 17, 2020
SUBMISSION CONTROL NO: 242770
All trademarks used under license.
© 2020 Janssen Inc.
_242770 APM.docx _
_EDMS-RIM-101028v6.0 _
_Page 2 of 39 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................15
DRUG INTERACTIONS
..................................................................................................17
DOSAGE AND ADMINISTRATION
..............................................................................18
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................24
STORAGE AND STABILITY
..........................................................................................26
SPECIAL HANDLING INSTRUCTIONS
.............................................................
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