MAXIMUM STRENGTH PEPCID AC TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

FAMOTIDINE

Tersedia dari:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

Kode ATC:

A02BA03

INN (Nama Internasional):

FAMOTIDINE

Dosis:

20MG

Bentuk farmasi:

TABLET

Komposisi:

FAMOTIDINE 20MG

Rute administrasi :

ORAL

Unit dalam paket:

5/25

Jenis Resep:

OTC

Area terapi:

HISTAMINE H2-ANTAGONISTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2011-12-06

Karakteristik produk

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
........................................................................................