COLD + SINUS TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

MAH:

VITA HEALTH PRODUCTS INC

ATC_code:

M01AE51

INN:

IBUPROFEN, COMBINATIONS

dosage:

200MG; 30MG

pharmaceutical_form:

TABLET

composition:

IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG

administration_route:

ORAL

units_in_package:

10/20/40/50/72/96/100

prescription_type:

OTC

therapeutic_area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0222394001; AHFS:

authorization_status:

APPROVED

authorization_date:

2010-06-08

SPC

Vita Health Products Inc.
Page 1
of 49
PRODUCT MONOGRAPH
COLD + SINUS
Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP
Ibuprofen 200 mg, Pseudoephedrine Hydrochloride 30 mg
Caplets
Analgesic/Antipyretic/Nasal Decongestant
Vita Health Products Inc.
Date of Revision:
150 Beghin Avenue
September 1, 2020
Winnipeg, Manitoba Canada, R2J 3W2
Control No. 242681
Vita Health Products Inc.
Page 2
of 49
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION....................................................................................
3
SUMMARY PRODUCT INFORMATION
..........................................................................................................
3
INDICATIONS AND CLINICAL
USE................................................................................................................
3
CONTRAINDICATIONS
.....................................................................................................................................
3
WARNINGS AND PRECAUTIONS
...................................................................................................................
5
ADVERSE REACTIONS
...................................................................................................................................
11
DRUG INTERACTIONS
....................................................................................................................................
18
DOSAGE AND ADMINISTRATION
................................................................................................................
21
OVERDOSAGE
..................................................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
..............................................................................................
24
STORAGE AND STABILITY
...........................................................................................................................
28
SPECIAL HANDLING INSTRUCTION
..