ADVIL COLD & FLU TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

DIPHENHYDRAMINE CITRATE; IBUPROFEN

Dostupno od:

GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC

ATC koda:

M01AE51

INN (International ime):

IBUPROFEN, COMBINATIONS

Doziranje:

38MG; 200MG

Farmaceutski oblik:

TABLET

Sastav:

DIPHENHYDRAMINE CITRATE 38MG; IBUPROFEN 200MG

Administracija rute:

ORAL

Jedinice u paketu:

2/10/20/40/72/80/180

Tip recepta:

OTC

Područje terapije:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Proizvod sažetak:

Active ingredient group (AIG) number: 0252877001; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2011-02-24

Svojstava lijeka

_ _
_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
...........................