ZANTAC MAXIMUM STRENGTH NON-PRESCRIPTION TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Available from:

SANOFI CONSUMER HEALTH INC

ATC code:

A02BA02

INN (International Name):

RANITIDINE

Dosage:

150MG

Pharmaceutical form:

TABLET

Composition:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 150MG

Administration route:

ORAL

Units in package:

3/8/16/24/28/48/50/65/95

Prescription type:

OTC

Therapeutic area:

HISTAMINE H2-ANTAGONISTS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2022-02-18

Summary of Product characteristics

_ _
_ZANTAC_
_®_
_ and ZANTAC_
_®_
_ Maximum Strength Non-Prescription Tablets _
_Page 1 of 35_
PRODUCT MONOGRAPH
ZANTAC
®
Ranitidine Tablets USP 75 mg (as ranitidine hydrochloride)
ZANTAC
® MAXIMUM STRENGTH NON-PRESCRIPTION
Ranitidine Tablets USP 150 mg (as ranitidine hydrochloride)
Histamine H
2
-receptor antagonist
Sanofi Consumer Health Inc.
2905 Place Louis-R. Renaud
Laval, QC, Canada H7V 0A3
Date of Revision:
December 5, 2019
Submission Control No: 231962
_ _
_ZANTAC_
_®_
_ and ZANTAC_
_®_
_ Maximum Strength Non-Prescription Tablets _
_Page 2 of 35 _
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
..............................................................................10
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
...............................................................................18
PHARMACEUTICAL INFORMATION
.........