PEPCID AC TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

FAMOTIDINE

Disponible depuis:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

Code ATC:

A02BA03

DCI (Dénomination commune internationale):

FAMOTIDINE

Dosage:

10MG

forme pharmaceutique:

TABLET

Composition:

FAMOTIDINE 10MG

Mode d'administration:

ORAL

Unités en paquet:

18/30/60

Type d'ordonnance:

OTC

Domaine thérapeutique:

HISTAMINE H2-ANTAGONISTS

Descriptif du produit:

Active ingredient group (AIG) number: 0118722003; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2011-12-02

Résumé des caractéristiques du produit

_PEPCID AC_
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PRODUCT MONOGRAPH
PEPCID AC
®
famotidine tablets
FILM COATED TABLETS 10 MG
Mfr.
Std.
HISTAMINE H
2
RECEPTOR ANTAGONIST
McNeil Consumer Healthcare,
division of Johnson & Johnson Inc.
88 McNabb Street
Markham, Ontario
L3R 5L2
Date of Preparation:
February 14, 1996
Date of Revision:
May 24, 2019
Submission Control No: 225990
_PEPCID AC_
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_PEPCID AC_
_®_
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
.........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
....................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
....................................................................................................4
DRUG INTERACTIONS
....................................................................................................5
DOSAGE AND ADMINISTRATION
................................................................................5
OVERDOSAGE
...................................................................................................................6
ACTION AND CLINICAL PHARMACOLOGY
...............................................................6
STORAGE AND STABILITY
............................................................................................8
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................8
PART II: SCIENTIFIC
INFORMATION................................................................................12
PHARMACEUTICAL INFORMATION
..........................................................................12
CLINICAL TRIALS
.......................................................