TYLENOL WITH CODEINE NO. 3 - TAB TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

ACETAMINOPHEN; CODEINE PHOSPHATE; CAFFEINE

זמין מ:

JANSSEN INC

קוד ATC:

N02AJ06

INN (שם בינלאומי):

CODEINE AND PARACETAMOL

כמות:

300MG; 30MG; 15MG

טופס פרצבטיות:

TABLET

הרכב:

ACETAMINOPHEN 300MG; CODEINE PHOSPHATE 30MG; CAFFEINE 15MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

500

סוג מרשם:

Narcotic (CDSA I)

איזור תרפויטי:

OPIATE AGONISTS

leaflet_short:

Active ingredient group (AIG) number: 0311391005; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2020-09-25

מאפייני מוצר

_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
.............................................................