TYLENOL WITH CODEINE NO. 3 - TAB TABLET
Țară: Canada
Limbă: engleză
Sursă: Health Canada
Caracteristicilor produsului
(SPC)
17-09-2020
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Trimite cerere.
Trimite cerere.
Ingredient activ:
ACETAMINOPHEN; CODEINE PHOSPHATE; CAFFEINE
Disponibil de la:
JANSSEN INC
Codul ATC:
N02AJ06
INN (nume internaţional):
CODEINE AND PARACETAMOL
Dozare:
300MG; 30MG; 15MG
Forma farmaceutică:
TABLET
Compoziție:
ACETAMINOPHEN 300MG; CODEINE PHOSPHATE 30MG; CAFFEINE 15MG
Calea de administrare:
ORAL
Unități în pachet:
500
Tip de prescriptie medicala:
Narcotic (CDSA I)
Zonă Terapeutică:
OPIATE AGONISTS
Rezumat produs:
Active ingredient group (AIG) number: 0311391005; AHFS:
Statutul autorizaţiei:
CANCELLED POST MARKET
Data de autorizare:
2020-09-25
Caracteristicilor produsului
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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.
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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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