ACID REDUCER TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Available from:

APOTEX INC

ATC code:

A02BA02

INN (International Name):

RANITIDINE

Dosage:

150MG

Pharmaceutical form:

TABLET

Composition:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 150MG

Administration route:

ORAL

Units in package:

24

Prescription type:

OTC

Therapeutic area:

HISTAMINE H2-ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0115150002; AHFS:

Authorization status:

APPROVED

Authorization date:

2007-06-06

Summary of Product characteristics

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PRODUCT MONOGRAPH
ACID REDUCER
Ranitidine Tablets USP
75 mg and 150 mg Ranitidine (as Ranitidine Hydrochloride)
Histamine H
2
-receptor antagonist
APOTEX INC.,
Date of Revision:
150 Signet Drive
January 24, 2020
Toronto, Ontario
M9L 1T9
Submission Control No.: 238800
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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
.....................................................................................
4
ADVERSE REACTIONS
.......................................................................................................
5
DRUG INTERACTIONS
........................................................................................................
7
DOSAGE AND ADMINISTRATION
...................................................................................
9
OVERDOSAGE
....................................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 10
STORAGE AND STABILITY
..............................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 15
PART II: SCIENTIFIC INFORMATION
..................................................................................
17
PHARMACEUTICAL INFORMATION
.............................................................................
17
DETAILED PHARMACOLOGY
.........................................................................................
18
TOXICOLOGY
.............