ADVIL COLD & FLU TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DIPHENHYDRAMINE CITRATE; IBUPROFEN

Tersedia dari:

GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC

Kode ATC:

M01AE51

INN (Nama Internasional):

IBUPROFEN, COMBINATIONS

Dosis:

38MG; 200MG

Bentuk farmasi:

TABLET

Komposisi:

DIPHENHYDRAMINE CITRATE 38MG; IBUPROFEN 200MG

Rute administrasi :

ORAL

Unit dalam paket:

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

Jenis Resep:

OTC

Area terapi:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2011-02-24

Karakteristik produk

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