Држава: Канада
Језик: Енглески
Извор: Health Canada
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
R01BA52
PSEUDOEPHEDRINE, COMBINATIONS
5MG; 120MG
TABLET (EXTENDED-RELEASE)
CETIRIZINE HYDROCHLORIDE 5MG; PSEUDOEPHEDRINE HYDROCHLORIDE 120MG
ORAL
10/20
OTC
SECOND GENERATION ANTIHISTAMINES
Active ingredient group (AIG) number: 0247823001; AHFS:
APPROVED
2007-01-16
_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 ............. Прочитајте комплетан документ