EXTRA STRENGTH TYLENOL NIGHTTIME TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
23-06-2020
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Active ingredient:
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Available from:
MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
ATC code:
N02BE51
INN (International Name):
ACETAMINOPHEN, COMB EXCL PSYCHOLEPTICS
Dosage:
500MG; 25MG
Pharmaceutical form:
TABLET
Composition:
ACETAMINOPHEN 500MG; DIPHENHYDRAMINE HYDROCHLORIDE 25MG
Administration route:
ORAL
Units in package:
16/40
Prescription type:
OTC
Therapeutic area:
MISCELLANEOUS ANALGESICS AND ANTIPYRETICS
Product summary:
Active ingredient group (AIG) number: 0233808001; AHFS:
Authorization status:
APPROVED
Authorization date:
2012-05-14
Summary of Product characteristics
_ _
_Extra Strength TYLENOL_
_®_
_ Nighttime Product Monograph _
_Page 1 of 47_
PRODUCT MONOGRAPH
EXTRA STRENGTH
TYLENOL
®
NIGHTTIME
Acetaminophen 500 mg and Diphenhydramine Hydrochloride 25 mg Caplets
Analgesic/Sleep Aid
Submission Control No: 237375
McNeil Consumer Healthcare
division of Johnson & Johnson Inc.
88 McNabb Street
Markham, Ontario
Canada L3R 5L2
Date of Revision:
March 20, 2020
_ _
_Extra Strength TYLENOL_
_®_
_ Nighttime Product Monograph _
_Page 2 of 47_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................26
SPECIAL HANDLING INSTRUCTIONS
.......................................................................26
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................26
PART II: SCIENTIFIC INFORMATION
................................................................................27
PHARMACEUTICAL INFORMA
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