COLD AND SINUS NIGHTTIME RELIEF TABLET

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE; ACETAMINOPHEN

Доступно од:

VITA HEALTH PRODUCTS INC

АТЦ код:

N02BE51

INN (Међународно име):

ACETAMINOPHEN, COMB EXCL PSYCHOLEPTICS

Дозирање:

6.25MG; 30MG; 500MG

Фармацеутски облик:

TABLET

Састав:

DOXYLAMINE SUCCINATE 6.25MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG; ACETAMINOPHEN 500MG

Пут администрације:

ORAL

Јединице у пакету:

12/24

Тип рецептора:

OTC

Терапеутска област:

MISCELLANEOUS ANALGESICS AND ANTIPYRETICS

Резиме производа:

Active ingredient group (AIG) number: 0337541001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2012-05-02

Карактеристике производа

Page 1 of 66
PRODUCT MONOGRAPH
COLD + SINUS NIGHTTIME
Ibuprofen 200 mg, Pseudoephedrine Hydrochloride 30 mg
and Chlorpheniramine Maleate 2 mg
Tablets
Analgesic/Antipyretic/Nasal Decongestant/Antihistamine
Vita Health Products Inc.
Date of Revision:
150 Beghin Avenue
October 31, 2011
Winnipeg, Manitoba Canada, R2J 3W2
Control# 149333
Page 2 of 66
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................................................................................................12
DRUG INTERACTIONS
................................................................................................20
DOSAGE AND ADMINISTRATION
............................................................................24
OVERDOSAGE...............................................................................................................25
ACTION AND CLINICAL
PHARMACOLOGY...........................................................28
STORAGE AND STABILITY
........................................................................................33
SPECIAL HANDLING
INSTRUCTIONS......................................................................33
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................33
PART II: SCIENTIFIC INFORMATION
................................................................................34
PHARMACEUTICAL
INFORMATION........................................................................34
CLINICAL TRIALS
..............................................................