ADVIL HEADACHE & MIGRAINE PAIN EXTRA STRENGTH CAPLETS TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

IBUPROFEN (IBUPROFEN SODIUM DIHYDRATE)

Commercializzato da:

PFIZER CONSUMER HEALTHCARE A DIVISION OF PFIZER CANADA ULC

Codice ATC:

M01AE01

INN (Nome Internazionale):

IBUPROFEN

Dosaggio:

400MG

Forma farmaceutica:

TABLET

Composizione:

IBUPROFEN (IBUPROFEN SODIUM DIHYDRATE) 400MG

Via di somministrazione:

ORAL

Confezione:

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

Tipo di ricetta:

OTC

Area terapeutica:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

CANCELLED PRE MARKET

Data dell'autorizzazione:

2018-08-02

Scheda tecnica

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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