AERIUS DOUBLE ACTION 12 HOUR TABLET (EXTENDED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DESLORATADINE; PSEUDOEPHEDRINE SULFATE

Available from:

BAYER INC

ATC code:

R01BA52

INN (International Name):

PSEUDOEPHEDRINE, COMBINATIONS

Dosage:

2.5MG; 120MG

Pharmaceutical form:

TABLET (EXTENDED-RELEASE)

Composition:

DESLORATADINE 2.5MG; PSEUDOEPHEDRINE SULFATE 120MG

Administration route:

ORAL

Units in package:

2/4/7/10/14/20/30

Prescription type:

OTC

Therapeutic area:

SECOND GENERATION ANTIHISTAMINES

Product summary:

Active ingredient group (AIG) number: 0252460001; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-12-05

Summary of Product characteristics

_< AERIUS® SINUS + ALLERGY > _
_ _
_< Desloratadine 2.5 mg & Pseudoephedrine sulfate 120 mg> _
_Page 1 of 36_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
AERIUS® SINUS + ALLERGY
Desloratadine and Pseudoephedrine sulfate Extended-Release Tablets
Extended-release tablets, Desloratadine 2.5 mg / Pseudoephedrine
Sulfate 120 mg, Oral
Histamine H1 Receptor Antagonist / Sympathomimetic Amine
Bayer Inc
Date of Authorization: February 1
st
, 2010
2920 Matheson Blvd. E
Date of Revision: February 20
th
, 2024
Mississauga, ON
L4W 5R6
Submission Control Number: 278741
® TM see www.bayer.ca/tm-mc
_ _
_< AERIUS® SINUS + ALLERGY > _
_ _
_<_
_Desloratadine 2.5 mg & Pseudoephedrine sulfate 120 mg> _
_Page 2 of 36_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4
1 INDICATIONS ...........................................................................................................................
4
1.1 Pediatrics
...............................................................................................................................
4
1.2 Geriatrics
...............................................................................................................................
4
2 CONTRAINDICATIONS .............................................................................................................
4
3 SERIOUS WARNINGS AND PRECAUTIONS BOX ......................................................................
4
4 DOSAGE AND ADMINISTRATION ............................................................................................
5
4.1 Dosing Considerations
..........................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
.....................................................................
5
4.4 Administration
...............................