REACTINE COMPLETE TABLET (EXTENDED-RELEASE)

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Verfügbar ab:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

ATC-Code:

R01BA52

INN (Internationale Bezeichnung):

PSEUDOEPHEDRINE, COMBINATIONS

Dosierung:

5MG; 120MG

Darreichungsform:

TABLET (EXTENDED-RELEASE)

Zusammensetzung:

CETIRIZINE HYDROCHLORIDE 5MG; PSEUDOEPHEDRINE HYDROCHLORIDE 120MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

10/20

Verschreibungstyp:

OTC

Therapiebereich:

SECOND GENERATION ANTIHISTAMINES

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2007-01-16

Fachinformation

_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
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.............