REACTINE COMPLETE TABLET (EXTENDED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Available from:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

ATC code:

R01BA52

INN (International Name):

PSEUDOEPHEDRINE, COMBINATIONS

Dosage:

5MG; 120MG

Pharmaceutical form:

TABLET (EXTENDED-RELEASE)

Composition:

CETIRIZINE HYDROCHLORIDE 5MG; PSEUDOEPHEDRINE HYDROCHLORIDE 120MG

Administration route:

ORAL

Units in package:

10/20

Prescription type:

OTC

Therapeutic area:

SECOND GENERATION ANTIHISTAMINES

Product summary:

Active ingredient group (AIG) number: 0247823001; AHFS:

Authorization status:

APPROVED

Authorization date:

2007-01-16

Summary of Product characteristics

_Product Monograph Master Template _
_Template Date: September 2020 _
_REACTINE® COMPLETE, Cetirizine Hydrochloride and Pseudoephedrine
Hydrochloride, Extended-Release _
_Tablets _
_Page 1 of 34 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
REACTINE
®
COMPLETE
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Extended-Release Tablets
Extended-Release Tablets, 5 mg Cetirizine Hydrochloride and 120 mg
Pseudoephedrine
Hydrochloride, Oral
McNeil Standard
Histamine H
1
Receptor Antagonist/Sympathomimetic Amine
McNeil Consumer Healthcare
division of Johnson & Johnson Inc.
88 McNabb Street
Markham, Canada
L3R 5L2
Date of Initial Authorization:
SEP 30, 2002
Date of Revision:
DEC 15, 2023
Submission Control Number: 275440
_ _
_Product Monograph Master Template _
_Template Date: September 2020 _
_REACTINE® COMPLETE, Cetirizine Hydrochloride and Pseudoephedrine
Hydrochloride, Extended-Release _
_Tablets _
_Page 2 of 34_
RECENT MAJOR LABEL CHANGES
Section 7: Warnings and Precautions
05/2019
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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