Страна: Канада
Язык: английский
Источник: Health Canada
DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE; ACETAMINOPHEN
VITA HEALTH PRODUCTS INC
N02BE51
ACETAMINOPHEN, COMB EXCL PSYCHOLEPTICS
6.25MG; 30MG; 500MG
TABLET
DOXYLAMINE SUCCINATE 6.25MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG; ACETAMINOPHEN 500MG
ORAL
12/24
OTC
MISCELLANEOUS ANALGESICS AND ANTIPYRETICS
Active ingredient group (AIG) number: 0337541001; AHFS:
APPROVED
2012-05-02
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 .............................................................. Прочитать полный документ