MAXIMUM STRENGTH PEPCID AC TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

FAMOTIDINE

Disponible des:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

Codi ATC:

A02BA03

Designació comuna internacional (DCI):

FAMOTIDINE

Dosis:

20MG

formulario farmacéutico:

TABLET

Composición:

FAMOTIDINE 20MG

Vía de administración:

ORAL

Unidades en paquete:

5/25

tipo de receta:

OTC

Área terapéutica:

HISTAMINE H2-ANTAGONISTS

Resumen del producto:

Active ingredient group (AIG) number: 0118722001; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2011-12-06

Fitxa tècnica

PRODUCT MONOGRAPH
MAXIMUM STRENGTH PEPCID
®
AC
famotidine tablets
FILM COATED TABLETS 20 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:
Nov 10, 2011
Date of Revision:
May 24, 2019
Submission Control No: 225990
_MAXIMUM STRENGTH 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
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND ADMINISTRATION
................................................................................7
OVERDOSAGE
.................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
...............................................................8
STORAGE AND STABILITY
..........................................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
..............................................13
PART II: SCIENTIFIC
INFORMATION................................................................................14
PHARMACEUTICAL INFORMATION
..........................................................................14
CLINICAL TRIALS
........................................................................................