COLD + SINUS CAPLETS TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Dostupné s:

VITA HEALTH PRODUCTS INC

ATC kód:

M01AE51

INN (Mezinárodní Name):

IBUPROFEN, COMBINATIONS

Dávkování:

200MG; 30MG

Léková forma:

TABLET

Složení:

IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG

Podání:

ORAL

Jednotky v balení:

10/20

Druh předpisu:

OTC

Terapeutické oblasti:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2006-10-17

Charakteristika produktu

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PRODUCT MONOGRAPH
COLD + SINUS CAPLETS
Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP
Ibuprofen 200 mg, Pseudoephedrine Hydrochloride 30 mg
USP
Analgesic/Antipyretic/Nasal Decongestant
Vita Health Products Inc.
150 Beghin Avenue
Winnipeg, Manitoba
Canada, R2J 3W2
Control No. 151199
Date of Revision:
January 30, 2012
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_Page 2 of 50_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
ADVERSE
REACTIONS..................................................................................................11
DRUG INTERACTIONS
..................................................................................................17
DOSAGE AND
ADMINISTRATION..............................................................................20
OVERDOSAGE
...............................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................23
STORAGE AND
STABILITY..........................................................................................28
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................28
PART II: SCIENTIFIC INFORMATION
...............................................................................29
PHARMACEUTICAL
INFORMATION..........................................................................29
CLINICAL
TRIALS..........................................................................................................31
DETAILED
PHARMACOLOGY.....................................................................................33
TOXICOLOGY
.......