EXTRA STRENGTH TYLENOL NIGHTTIME TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE

Dostupné z:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

ATC kód:

N02BE51

INN (Medzinárodný Name):

ACETAMINOPHEN, COMB EXCL PSYCHOLEPTICS

Dávkovanie:

500MG; 25MG

Forma lieku:

TABLET

Zloženie:

ACETAMINOPHEN 500MG; DIPHENHYDRAMINE HYDROCHLORIDE 25MG

Spôsob podávania:

ORAL

Počet v balení:

16/40

Typ predpisu:

OTC

Terapeutické oblasti:

MISCELLANEOUS ANALGESICS AND ANTIPYRETICS

Prehľad produktov:

Active ingredient group (AIG) number: 0233808001; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2012-05-14

Súhrn charakteristických

_ _
_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