CHILDREN'S MOTRIN SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IBUPROFEN

Available from:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

ATC code:

M01AE01

INN (International Name):

IBUPROFEN

Dosage:

100MG

Pharmaceutical form:

SUSPENSION

Composition:

IBUPROFEN 100MG

Administration route:

ORAL

Units in package:

120ML

Prescription type:

OTC

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0108883005; AHFS:

Authorization status:

APPROVED

Authorization date:

2000-06-13

Summary of Product characteristics

_Children’s MOTRIN_
_®_
_, Ibuprofen Oral Suspension, 100 mg/5 mL _
_Infants’ MOTRIN_
_®_
_, Ibuprofen Oral Suspension, 40 mg/10 mL _
_Children’s/Junior Strength MOTRIN_
_®_
_ Chewable Tablets, Ibuprofen Tablets, 50 mg and 100 mg _
_ _
_Page 1 of 66_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
CHILDREN’S MOTRIN®
Ibuprofen Oral Suspension
Suspension, 100 mg/5 mL, Oral
McNeil Std.
Analgesic/Antipyretic INFANTS’ MOTRIN®
Ibuprofen Oral Suspension
Suspension, 40 mg/10 mL, Oral
McNeil Std.
Analgesic/Antipyretic
CHILDREN’S/JUNIOR STRENGTH MOTRIN® CHEWABLE TABLETS
Ibuprofen Tablets
Tablet, 50 mg and 100 mg, Oral
McNeil Std.
Analgesic/Antipyretic
McNeil Consumer Healthcare
Division of Johnson & Johnson Inc.
88 McNabb Street
Markham, Canada
L3R 5L2
Date of Initial Authorization:
[OCT 14,1998]
Date of Revision:
March 30, 2023
Submission Control Number: 265393
_ _
_Children’s MOTRIN_
_®_
_, Ibuprofen Oral Suspension, 100 mg/5 mL _
_Infants’ MOTRIN_
_®_
_, Ibuprofen Oral Suspension, 40 mg/10 mL _
_Children’s/Junior Strength MOTRIN_
_®_
_ Chewable Tablets, Ibuprofen Tablets, 50 mg and 100 mg _
_Page 2 of 66_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
[03/2023]
7 WARNINGS AND PRECAUTIONS
Monitoring and Laboratory Tests
[03/2023]
7 WARNINGS AND PRECAUTIONS
7.1.1 Pregnant Women
[03/2023]
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
............................................................................................
1
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
2
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
.......................................................................