MOTRIN 200MG TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

IBUPROFEN

Διαθέσιμο από:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

Φαρμακολογική κατηγορία (ATC):

M01AE01

INN (Διεθνής Όνομα):

IBUPROFEN

Δοσολογία:

200MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

IBUPROFEN 200MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

10/24/50/100/150

Τρόπος διάθεσης:

OTC

Θεραπευτική περιοχή:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0108883004; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2013-02-14

Αρχείο Π.Χ.Π.

MOTRIN® 200 mg / MOTRIN® 300 mg / MOTRIN® 400 mg (Ibuprofen Tablets
USP)
_ _
_Page 1 of 41 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
MOTRIN
® 200 MG
MOTRIN
® 300 MG
MOTRIN
® 400 MG
Ibuprofen Tablets
Tablets, 200 mg / 300 mg / 400 mg, Oral
USP
Non-Steroidal Anti-inflammatory Drug
Analgesic, Antipyretic Agent
McNeil Consumer Healthcare
Division of Johnson & Johnson Inc.
88 McNabb Street
Markham, Canada
L3R 5L2
Date of Initial
Authorization:
[FEB 14,2013]
Date of Revision:
April 04, 2023
Submission Control Number: 265403
_ _
MOTRIN® 200 mg / MOTRIN® 300 mg / MOTRIN® 400 mg (Ibuprofen Tablets
USP)
_ _
_Page 2 of 41_
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
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................