ADVIL HEADACHE & MIGRAINE PAIN EXTRA STRENGTH CAPLETS TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

IBUPROFEN (IBUPROFEN SODIUM DIHYDRATE)

Dostępny od:

PFIZER CONSUMER HEALTHCARE A DIVISION OF PFIZER CANADA ULC

Kod ATC:

M01AE01

INN (International Nazwa):

IBUPROFEN

Dawkowanie:

400MG

Forma farmaceutyczna:

TABLET

Skład:

IBUPROFEN (IBUPROFEN SODIUM DIHYDRATE) 400MG

Droga podania:

ORAL

Sztuk w opakowaniu:

1/10/12/20/30/60/67/77/180

Typ recepty:

OTC

Dziedzina terapeutyczna:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0108883002; AHFS:

Status autoryzacji:

CANCELLED PRE MARKET

Data autoryzacji:

2018-08-02

Charakterystyka produktu

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_Pfizer Consumer Healthcare, a division of Pfizer Canada Inc. _
_Page 1 of 64 _
PRODUCT MONOGRAPH
ADVIL
®
HEADACHE & MIGRAINE PAIN CAPLETS
200 mg Ibuprofen Caplets (provided as 256 mg Ibuprofen Sodium
Dihydrate)
ADVIL
®
HEADACHE & MIGRAINE PAIN TABLETS
200 mg Ibuprofen Tablets (provided as 256 mg Ibuprofen Sodium
Dihydrate)
ADVIL
®
HEADACHE & MIGRAINE PAIN EXTRA STRENGTH CAPLETS
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.: 179222
Date of Preparation:
May 12, 2015
Date of Revision :
July 29, 2016
_ _
_Pfizer Consumer Healthcare, a division of Pfizer Canada Inc. _
_Page 2 of 64 _
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 INST