Država: Kanada
Jezik: angleščina
Source: Health Canada
CAFFEINE; CODEINE PHOSPHATE; ACETAMINOPHEN
MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
N02AJ06
CODEINE AND PARACETAMOL
15MG; 8MG; 300MG
TABLET
CAFFEINE 15MG; CODEINE PHOSPHATE 8MG; ACETAMINOPHEN 300MG
ORAL
30/100
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0311391002; AHFS:
CANCELLED POST MARKET
2016-09-29
_ _ _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. Preberite celoten dokument