TYLENOL EXTRA STRENGTH CAPLETS TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ACETAMINOPHEN

Available from:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

ATC code:

N02BE01

INN (International Name):

ACETAMINOPHEN (PARACETAMOL)

Dosage:

500MG

Pharmaceutical form:

TABLET

Composition:

ACETAMINOPHEN 500MG

Administration route:

ORAL

Units in package:

10/24/50/100/150

Prescription type:

OTC

Therapeutic area:

MISCELLANEOUS ANALGESICS AND ANTIPYRETICS

Product summary:

Active ingredient group (AIG) number: 0102009002; AHFS:

Authorization status:

MARKETED

Authorization date:

1985-12-31

Summary of Product characteristics

Page 1 of 36
FULL PRESCRIBING INFORMATION
TYLENOL
®
Regular Strength (DIN 00559393)
Acetaminophen Tablets USP 325 mg
TYLENOL
®
Regular Strength Caplets (DIN 00723894)
Acetaminophen Tablets USP 325 mg
TYLENOL
®
Extra Strength (DIN 00559407)
Acetaminophen Tablets USP 500 mg
TYLENOL
®
Extra Strength Caplets (DIN 00723908)
Acetaminophen
Tablets USP 500 mg
TYLENOL
®
Liquid Gels (DIN 02407612)
Acetaminophen Capsule 325 mg
TYLENOL
®
Rapid Release (DIN 00863270)
Acetaminophen Tablets USP 500 mg
TYLENOL
®
Arthritis Pain 8 (DIN 02238885)
Acetaminophen Tablets (Extended Release) 650 mg
TYLENOL
®
Muscle & Body (DIN
02246060
)
Acetaminophen Tablets (Extended Release) 650 mg
Children’s TYLENOL
®
Chewables (02241361)
Acetaminophen Tablets USP 160 mg
(Bubblegum and Grape)
Children’s TYLENOL
®
Fastmelts (DIN 02347792)
Acetaminophen Tablets USP 160 mg (Grape)
Children’s TYLENOL
®
(DIN 02046040)
Acetaminophen Suspension USP 160 mg/5 mL
(Banana Berry, Bubblegum, Grape, Dye-Free Cherry and Dye-Free Berry)
Infants’ TYLENOL
®
(DIN 02046059)
Acetaminophen Suspension USP 80 mg / 1 mL
(Cherry and Dye-Free Grape)
Children’s TYLENOL
®
Easy Dissolve (DIN XXXXXXXX)
Acetaminophen Powder 160 mg (Wild Berry)
Analgesic / Antipyretic
This prescribing information is the exclusive property of McNeil
Consumer Healthcare, division of Johnson &
Johnson Inc. It may not be copied, in whole or in part, without the
expressed written permission of McNeil
Consumer Healthcare, division of Johnson & Johnson Inc.
McNeil Consumer Healthcare
Date of Preparation:
Page 2 of 36
division of Johnson & Johnson Inc. September 2, 2005
88 McNabb Street
Date of Revision
Markham, Ontario
June 15, 2021
L3R 5L2
CONTROL #
TYLENOL
®
McNeil Consumer Healthcare, division of Johnson & Johnson Inc.
_ _
_ACETAMINOPHEN_
ANALGESIC – ANTIPYRETIC
HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
TABLE 1: PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM /
STRENGTH
CLINICALLY RELEVANT INACTIVE
INGREDIENTS
Page 3 of 36
Oral
Suspension /
80 mg/1 mL