TYLENOL WITH CODEINE NO. 4 TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

ACETAMINOPHEN; CODEINE PHOSPHATE

Tilgængelig fra:

JANSSEN INC

ATC-kode:

N02AJ06

INN (International Name):

CODEINE AND PARACETAMOL

Dosering:

300MG; 60MG

Lægemiddelform:

TABLET

Sammensætning:

ACETAMINOPHEN 300MG; CODEINE PHOSPHATE 60MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Narcotic (CDSA I)

Terapeutisk område:

OPIATE AGONISTS

Produkt oversigt:

Active ingredient group (AIG) number: 0211376001; AHFS:

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2020-09-25

Produktets egenskaber

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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.
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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