COLD AND SINUS NIGHTTIME RELIEF TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE; ACETAMINOPHEN

Dostopno od:

VITA HEALTH PRODUCTS INC

Koda artikla:

N02BE51

INN (mednarodno ime):

ACETAMINOPHEN, COMB EXCL PSYCHOLEPTICS

Odmerek:

6.25MG; 30MG; 500MG

Farmacevtska oblika:

TABLET

Sestava:

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

Pot uporabe:

ORAL

Enote v paketu:

12/24

Tip zastaranja:

OTC

Terapevtsko območje:

MISCELLANEOUS ANALGESICS AND ANTIPYRETICS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2012-05-02

Lastnosti izdelka

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
..............................................................