REACTINE CHEWABLE TABLETS 5 MG TABLET (CHEWABLE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CETIRIZINE HYDROCHLORIDE

Available from:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

ATC code:

R06AE07

INN (International Name):

CETIRIZINE

Dosage:

5MG

Pharmaceutical form:

TABLET (CHEWABLE)

Composition:

CETIRIZINE HYDROCHLORIDE 5MG

Administration route:

ORAL

Units in package:

100

Prescription type:

OTC

Therapeutic area:

SECOND GENERATION ANTIHISTAMINES

Product summary:

Active ingredient group (AIG) number: 0122686002; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2016-01-22

Summary of Product characteristics

-1-
_ _
PRODUCT MONOGRAPH
REACTINE
®
(CETIRIZINE HYDROCHLORIDE TABLETS, 5 MG, 10 MG)
REACTINE
® CHEWABLE TABLETS, 5 MG, 10 MG
(CETIRIZINE HYDROCHLORIDE TABLETS (CHEWABLE), 5 MG, 10 MG)
REACTINE
®
FAST MELT™ JUNIOR
(CETIRIZINE HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS, 10 MG)
REACTINE
® ALLERGY LIQUID GELS
(CETIRIZINE HYDROCHLORIDE CAPSULES, 10 MG)
REACTINE
®
(CETIRIZINE HYDROCHLORIDE SYRUP 5 MG/5 ML)
PR REACTINE
®
20 MG TABLET
(CETIRIZINE HYDROCHLORIDE TABLETS)
HISTAMINE H
1 RECEPTOR ANTAGONIST
DATE OF REVISION: JUNE 11, 2014
MCNEIL CONSUMER HEALTHCARE
DIVISION OF JOHNSON & JOHNSON INC.
88 MCNABB STREET
MARKHAM, CANADA
L3R 5L2
Submission Control No: 173699
_ _
_Appendix G - Product Monograph Template - Subsequent Entry Product _
_Page 2 of 40_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................................................
3
SUMMARY PRODUCT INFORMATION
.................................................................................................................
3
INDICATIONS AND CLINICAL USE
......................................................................................................................
3
CONTRAINDICATIONS
............................................................................................................................................
4
WARNINGS AND PRECAUTIONS
..........................................................................................................................
4
ADVERSE REACTIONS
............................................................................................................................................
5
DRUG INTERACTIONS
.............................................................................................................................................
8
DOSAGE AND
ADMINISTRATION.........................................................................................................................
9
OVERDOSAGE
.............................................