Država: Kanada
Jezik: angleščina
Source: Health Canada
DIPHENHYDRAMINE CITRATE; IBUPROFEN
GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC
M01AE51
IBUPROFEN, COMBINATIONS
38MG; 200MG
TABLET
DIPHENHYDRAMINE CITRATE 38MG; IBUPROFEN 200MG
ORAL
2/10/20/40/72/80/180
OTC
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0252877001; AHFS:
APPROVED
2011-02-24
_ _ _GlaxoSmithKline Consumer Healthcare Inc. _ _Page 1 of 51_ PRODUCT MONOGRAPH _ _ ADVIL COLD & FLU ADVIL PAIN & HEAD COLD NIGHT Ibuprofen and Diphenhydramine Citrate Caplets 200 mg/38 mg Analgesic/Antipyretic and Antihistamine GlaxoSmithKline Consumer Healthcare Inc. 7333 Mississauga Road Mississauga, Ontario Canada L5N 6L4 Date of Revision: June 5, 2020 Submission Control No.: 239352 _ _ _GlaxoSmithKline Consumer Healthcare Inc. _ _Page 2 of 51_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 ADVERSE REACTIONS ..................................................................................................12 DOSAGE AND ADMINISTRATION ..............................................................................22 OVERDOSAGE ................................................................................................................23 ACTION AND CLINICAL PHARMACOLOGY ............................................................24 STORAGE AND STABILITY ..........................................................................................28 SPECIAL HANDLING INSTRUCTIONS .......................................................................28 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................28 PART II: SCIENTIFIC INFORMATION ...............................................................................29 PHARMACEUTICAL INFORMATION ..........................................................................29 CLINICAL TRIALS ..........................................................................................................31 DETAILED PHARMACOLOGY ........................... Preberite celoten dokument