国: カナダ
言語: 英語
ソース: Health Canada
FAMOTIDINE
MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
A02BA03
FAMOTIDINE
20MG
TABLET
FAMOTIDINE 20MG
ORAL
5/25
OTC
HISTAMINE H2-ANTAGONISTS
Active ingredient group (AIG) number: 0118722001; AHFS:
APPROVED
2011-12-06
PRODUCT MONOGRAPH MAXIMUM STRENGTH PEPCID ® AC famotidine tablets FILM COATED TABLETS 20 MG Mfr. Std. HISTAMINE H 2 RECEPTOR ANTAGONIST McNeil Consumer Healthcare, division of Johnson & Johnson Inc. 88 McNabb Street Markham, Ontario L3R 5L2 Date of Preparation: Nov 10, 2011 Date of Revision: May 24, 2019 Submission Control No: 225990 _MAXIMUM STRENGTH PEPCID_ ® _AC _ _ _ _Page 1 of 22_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION .........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ....................................................................................................3 WARNINGS AND PRECAUTIONS ..................................................................................3 ADVERSE REACTIONS ....................................................................................................5 DRUG INTERACTIONS ....................................................................................................9 DOSAGE AND ADMINISTRATION ................................................................................7 OVERDOSAGE .................................................................................................................10 ACTION AND CLINICAL PHARMACOLOGY ...............................................................8 STORAGE AND STABILITY ..........................................................................................13 DOSAGE FORMS, COMPOSITION AND PACKAGING ..............................................13 PART II: SCIENTIFIC INFORMATION................................................................................14 PHARMACEUTICAL INFORMATION ..........................................................................14 CLINICAL TRIALS ........................................................................................ 完全なドキュメントを読む