MOTRIN LIQUID GELS 200MG CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
05-05-2023
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Active ingredient:
IBUPROFEN
Available from:
MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
ATC code:
M01AE01
INN (International Name):
IBUPROFEN
Dosage:
200MG
Pharmaceutical form:
CAPSULE
Composition:
IBUPROFEN 200MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
OTC
Therapeutic area:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0108883004; AHFS:
Authorization status:
APPROVED
Authorization date:
2013-02-14
Summary of Product characteristics
_ _
_ _
_MOTRIN_
®
_LIQUID GELS 200 mg and MOTRIN_
®
_LIQUID GELS 400 mg (Ibuprofen Capsules) _
_Page 1 of 50_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
MOTRIN®
LIQUID GELS 200 MG
Ibuprofen Capsules (free acid and potassium salt)
Capsule, 200 mg, Oral
MOTRIN®
LIQUID GELS 400 MG
Ibuprofen Capsules (free acid and potassium salt)
Capsule, 400 mg, Oral
Non-Steroidal Anti-inflammatory Drug
Analgesic/Antipyretic
McNeil Consumer Healthcare
Division of Johnson & Johnson Inc.
88 McNabb Street
Markham, Canada
L3R 5L2
Date of Initial Authorization:
[OCT 31,2007]
Date of Revision:
April 5, 2023
Submission Control Number: 265373
_ _
_MOTRIN_
®
_LIQUID GELS 200 mg and MOTRIN_
®
_LIQUID GELS 400 mg (Ibuprofen Capsules) _
_Page 2 of 50_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS
BOX
04/2023
7 WARNINGS AND PRECAUTIONS
Monitoring and
Laboratory Tests
04/2023
7 WARNINGS AND PRECAUTIONS
7.1.1 Pregnant
Women
04/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 6
4
DOSAGE A
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