MOTRIN 200MG TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

IBUPROFEN

Dostopno od:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

Koda artikla:

M01AE01

INN (mednarodno ime):

IBUPROFEN

Odmerek:

200MG

Farmacevtska oblika:

TABLET

Sestava:

IBUPROFEN 200MG

Pot uporabe:

ORAL

Enote v paketu:

10/24/50/100/150

Tip zastaranja:

OTC

Terapevtsko območje:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2013-02-14

Lastnosti izdelka

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
.................................................................................