TYLENOL NO.1 CAPLETS TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

CAFFEINE; CODEINE PHOSPHATE; ACETAMINOPHEN

Beschikbaar vanaf:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

ATC-code:

N02AJ06

INN (Algemene Internationale Benaming):

CODEINE AND PARACETAMOL

Dosering:

15MG; 8MG; 300MG

farmaceutische vorm:

TABLET

Samenstelling:

CAFFEINE 15MG; CODEINE PHOSPHATE 8MG; ACETAMINOPHEN 300MG

Toedieningsweg:

ORAL

Eenheden in pakket:

30/100

Prescription-type:

Narcotic (CDSA I)

Therapeutisch gebied:

OPIATE AGONISTS

Product samenvatting:

Active ingredient group (AIG) number: 0311391002; AHFS:

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2016-09-29

Productkenmerken

_ _
_Pristine Tylenol PI 06 Aug 2014.docx _
_Page 1 of 16 _
PRESCRIBING INFORMATION
N
TYLENOL
®
No. 1
acetaminophen, caffeine and codeine phosphate caplets
300 mg acetaminophen, 15 mg caffeine and 8 mg codeine phosphate
caplets
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
N
TYLENOL
® with Codeine No. 4
300 mg acetaminophen and 60 mg codeine phosphate tablets
acetaminophen and codeine phosphate tablets, USP
Analgesic-Antipyretic
NOT A PRODUCT MONOGRAPH
Janssen Inc.
200 Whitehall Drive
Markham, Ontario
L3R 0T5
McNeil Consumer Healthcare
DATE OF REVISION:
Division of Johnson & Johnson Inc.
August 6, 2014
88 McNabb St.
Markham, Ontario
L3R 5L2
www.janssen.ca
SUBMISSION CONTROL NO.: 174767, 174768, 175441, 175442
All trademarks used under license.
© 2014 Janssen Inc.
_ _
_Pristine Tylenol PI 06 Aug 2014.docx _
_Page 2 of 16 _
PRESCRIBING INFORMATION
N
TYLENOL
®
No. 1
acetaminophen, caffeine and codeine phosphate caplets
N
TYLENOL
®
with Codeine No. 2
N
TYLENOL
®
with Codeine No. 3
acetaminophen, caffeine and codeine phosphate tablets
N
TYLENOL
® with Codeine No. 4
acetaminophen and codeine phosphate tablets, USP
Analgesic-Antipyretic
CLINICAL PHARMACOLOGY
TYLENOL
®
acetaminophen and codeine phosphate and TYLENOL
®
acetaminophen, caffeine
and codeine phosphate are analgesic, antipyretic agents.
ACTION
TYLENOL
®
acetaminophen and codeine phosphate and TYLENOL
®
acetaminophen, caffeine
and codeine phosphate combine the analgesic effects of the centrally
acting analgesic codeine,
with a peripherally acting analgesic, acetaminophen. Caffeine
stimulates the central nervous
system (CNS) at all levels including the cerebral cortex. In addition,
it acts on the kidneys to
produce mild diuresis, stimulates cardiac muscle, and depresses smooth
muscle.