TYLENOL ARTHRITIS PAIN 8H TABLET (EXTENDED-RELEASE)

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:

650MG

Pharmaceutical form:

TABLET (EXTENDED-RELEASE)

Composition:

ACETAMINOPHEN 650MG

Administration route:

ORAL

Units in package:

24/50/100/170

Prescription type:

OTC

Therapeutic area:

MISCELLANEOUS ANALGESICS AND ANTIPYRETICS

Product summary:

Active ingredient group (AIG) number: 0102009008; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-10-04

Patient Information leaflet

TYLENOL 8 HR ARTHRITIS PAIN- ACETAMINOPHEN TABLET, EXTENDED RELEASE
JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION
----------
TYLENOL 8 HR ARTHRITIS PAIN
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH CAPLET)
Acetaminophen 650 mg
PURPOS E
Pain reliever/fever reducer
US ES
temporarily relieves minor aches and pains due to:
minor pain of arthritis
muscular aches
backache
premenstrual and menstrual cramps
the common cold
headache
toothache
temporarily reduces fever
WARNINGS
LIVER WARNING
This product contains acetaminophen. Severe liver damage may occur if
you take
more than 6 caplets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
ALLERGY ALERT: acetaminophen may cause severe skin reactions. Symptoms
may include:
skin reddening
blisters
rash
If a skin reaction occurs, stop use and seek medical help right away.
DO NOT USE
with any other drug containing acetaminophen (prescription or
nonprescription). If you are not sure
whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are allergic to acetaminophen or any of the inactive
ingredients in this product
ASK A DOCTOR BEFORE USE IF YOU HAVE liver disease
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking the blood
thinning drug warfarin
STOP USE AND ASK A DOCTOR IF
®
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present
These could be signs of a serious condition.
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
OVERDOSE WARNING
In case of overdose, get medical help or contact a Poison Control
Center right away. (1-800-222-1222)
Quick medical attention is critical for adults as well as for children
even if you do not notice any signs
or symptoms.
DIRECTIONS
DO NOT TAKE MORE THAN DIRECTED (SEE OVERDOSE WARNING)
adults
take 2 caplets every 8 hours
with water
swallow whole; do not crush,
chew, split

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