REACTINE COMPLETE TABLET (EXTENDED-RELEASE)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Tersedia dari:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

Kode ATC:

R01BA52

INN (Nama Internasional):

PSEUDOEPHEDRINE, COMBINATIONS

Dosis:

5MG; 120MG

Bentuk farmasi:

TABLET (EXTENDED-RELEASE)

Komposisi:

CETIRIZINE HYDROCHLORIDE 5MG; PSEUDOEPHEDRINE HYDROCHLORIDE 120MG

Rute administrasi :

ORAL

Unit dalam paket:

10/20

Jenis Resep:

OTC

Area terapi:

SECOND GENERATION ANTIHISTAMINES

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2007-01-16

Karakteristik produk

_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
.............