TYLENOL WITH CODEINE NO. 4 TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

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下载 产品特点 (SPC)
07-12-2021

有效成分:

ACETAMINOPHEN; CODEINE PHOSPHATE

可用日期:

JANSSEN INC

ATC代码:

N02AJ06

INN(国际名称):

CODEINE AND PARACETAMOL

剂量:

300MG; 60MG

药物剂型:

TABLET

组成:

ACETAMINOPHEN 300MG; CODEINE PHOSPHATE 60MG

给药途径:

ORAL

每包单位数:

100

处方类型:

Narcotic (CDSA I)

治疗领域:

OPIATE AGONISTS

產品總結:

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

授权状态:

CANCELLED POST MARKET

授权日期:

2020-09-25

产品特点

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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
                                
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