ADVIL HEADACHE TABLETS

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

IBUPROFEN (IBUPROFEN SODIUM DIHYDRATE)

Доступна з:

PFIZER CONSUMER HEALTHCARE A DIVISION OF PFIZER CANADA ULC

Код атс:

M01AE01

ІПН (Міжнародна Ім'я):

IBUPROFEN

Дозування:

200MG

Фармацевтична форма:

TABLET

Склад:

IBUPROFEN (IBUPROFEN SODIUM DIHYDRATE) 200MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

10/16/20/40/50/110/135/325/330

Тип рецепту:

OTC

Терапевтична области:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Огляд продуктів:

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

Статус Авторизація:

CANCELLED PRE MARKET

Дата Авторизація:

2018-08-02

Характеристики продукта

_ _
_Pfizer Consumer Healthcare, a division of Pfizer Canada Inc. _
_Page 1 of 67 _
PRODUCT MONOGRAPH
ADVIL
®
HEADACHE CAPLETS
200 mg Ibuprofen Caplets (provided as 256 mg Ibuprofen Sodium
Dihydrate)
ADVIL
®
HEADACHE TABLETS
200 mg Ibuprofen Tablets (provided as 256 mg Ibuprofen Sodium
Dihydrate)
ADVIL
®
HEADACHE EXTRA STRENGTH
400 mg Ibuprofen Caplets (provided as 512 mg Ibuprofen Sodium
Dihydrate)
Analgesic/Antipyretic
Pfizer Consumer Healthcare, a division of Pfizer Canada Inc.
450 – 55 Standish Court
Mississauga, Ontario
Canada L5R 4B2
Submission Control No.: 206535
Date of Preparation:
May 12, 2015
Date of Revision :
August 11, 2017
_ _
_Pfizer Consumer Healthcare, a division of Pfizer Canada Inc. _
_Page 2 of 67 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................4
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................20
DOSAGE AND ADMINISTRATION
..............................................................................24
OVERDOSAGE
................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
............................................................27
STORAGE AND STABILITY
..........................................................................................31
SPECIAL HANDLING INSTRUCTIONS
.............................................