ADVIL COLD & FLU TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

DIPHENHYDRAMINE CITRATE; IBUPROFEN

Disponível em:

GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC

Código ATC:

M01AE51

DCI (Denominação Comum Internacional):

IBUPROFEN, COMBINATIONS

Dosagem:

38MG; 200MG

Forma farmacêutica:

TABLET

Composição:

DIPHENHYDRAMINE CITRATE 38MG; IBUPROFEN 200MG

Via de administração:

ORAL

Unidades em pacote:

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

Tipo de prescrição:

OTC

Área terapêutica:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2011-02-24

Características técnicas

_ _
_GlaxoSmithKline Consumer Healthcare Inc. _
_Page 1 of 51_
PRODUCT MONOGRAPH
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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
...........................