Страна: Канада
Язык: английский
Источник: Health Canada
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
MARCAN PHARMACEUTICALS INC
M01AE51
IBUPROFEN, COMBINATIONS
200MG; 30MG
TABLET
IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG
ORAL
10/24/100
OTC
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0222394001; AHFS:
APPROVED
2016-08-23
Page 1 of 47 PRODUCT MONOGRAPH IBUPROFEN + PSEUDOEPHEDRINE CAPLETS Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP Ibuprofen 200 mg, Pseudoephedrine Hydrochloride 30 mg Caplets Analgesic/Antipyretic/Nasal Decongestant Marcan Pharmaceuticals Inc. Date of Preparation: 77 Auriga Drive, Unit #4 August 23, 2016 Ottawa, Ontario K2E 7Z7 Control# 197421 Page 2 of 47 _ _ 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 .................................................................................................................... 10 DRUG INTERACTIONS ..................................................................................................................... 17 DOSAGE AND ADMINISTRATION ................................................................................................. 20 OVERDOSAGE ................................................................................................................................... 20 ACTION AND CLINICAL PHARMACOLOGY ............................................................................... 22 STORAGE AND STABILITY ............................................................................................................ 26 SPECIAL HANDLING INSTRUCTION ............................................................................................ 26 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................................... Прочитать полный документ