CLARITIN ALLERGY + SINUS TABLET (IMMEDIATE AND EXTENDED RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PSEUDOEPHEDRINE SULFATE; LORATADINE

Available from:

BAYER INC

ATC code:

R01BA52

INN (International Name):

PSEUDOEPHEDRINE, COMBINATIONS

Dosage:

120MG; 5MG

Pharmaceutical form:

TABLET (IMMEDIATE AND EXTENDED RELEASE)

Composition:

PSEUDOEPHEDRINE SULFATE 120MG; LORATADINE 5MG

Administration route:

ORAL

Units in package:

10/20/30

Prescription type:

OTC

Therapeutic area:

SECOND GENERATION ANTIHISTAMINES

Product summary:

Active ingredient group (AIG) number: 0245861002; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-12-08

Summary of Product characteristics

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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
CLARITIN® ALLERGY + SINUS
Loratadine and Pseudoephedrine Sulfate
Modified-Release Tablets, Professed Standard
5 mg Loratadine and 120 mg Pseudoephedrine Sulfate; Oral
CLARITIN® ALLERGY + SINUS EXTRA STRENGTH
Loratadine and Pseudoephedrine Sulfate
Modified-Release Tablets, Professed Standard
10 mg Loratadine and 240 mg Pseudoephedrine Sulfate; Oral
Histamine H1 receptor antagonist/Sympathomimetic amine
Bayer Inc.
2920 Matheson Blvd. E
Mississauga, ON
L4W 5R6
Date of Initial Authorization:
Claritin® Allergy + Sinus:
2-Mar-1993
Claritin® Allergy +Sinus Extra
Strength:
4-Dec-2004
Date of Revision:
NOV-01-2022
Submission Control Number: 265671
® TM see www.bayer.ca/tm-mc
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TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
TABLE OF CONTENTS
...........................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 4
1.
INDICATIONS................................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics...................................................................................................................
4
2.
CONTRAINDICATIONS
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4
4.
DOSAGE AND ADMI