Land: Canada
Taal: Engels
Bron: Health Canada
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
M01AE51
IBUPROFEN, COMBINATIONS
200MG; 30MG
TABLET
IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG
ORAL
20/40
OTC
ALPHA-AND BETA-ADRENERGIC AGONISTS
Active ingredient group (AIG) number: 0222394001; AHFS:
CANCELLED POST MARKET
2016-08-05
PRODUCT MONOGRAPH MOTRIN® COLD & SINUS PAIN IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLETS, U.S.P. TABLETS THERAPEUTIC CLASSIFICATION ANALGESIC/ANTIPYRETIC/NASAL DECONGESTANT MCNEIL CONSUMER HEALTHCARE DATE OF REVISION: 88 MCNABB STREET FEBRUARY 26, 2009 MARKHAM, ONTARIO L3R 5L2 SUBMISSION CONTROL NUMBER: 128263 - 2 - TABLE OF CONTENTS I. Clinical Pharmacology.........................................................................................................3 II. Indications............................................................................................................................8 III. Contraindications .................................................................................................................8 IV. Warnings..............................................................................................................................9 V. Precautions...........................................................................................................................9 VI. Drug Interactions ...............................................................................................................10 VII. Adverse Reactions .............................................................................................................12 VIII. Dosage and Administration ...............................................................................................17 IX. Pharmaceutical Information...............................................................................................18 X. Availability of Dosage Forms............................................................................................20 XI. Information for the Consumer ...........................................................................................20 XII. Overdosage ........................................................................................................................22 XIII. Pharmacology ........................................................................... Lees het volledige document