ADVIL COLD, COUGH & FLU NIGHTTIME CAPSULE

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

IBUPROFEN; DIPHENHYDRAMINE HYDROCHLORIDE

Prieinama:

GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC

ATC kodas:

M01AE51

INN (Tarptautinis Pavadinimas):

IBUPROFEN, COMBINATIONS

Dozė:

200MG; 25MG

Vaisto forma:

CAPSULE

Sudėtis:

IBUPROFEN 200MG; DIPHENHYDRAMINE HYDROCHLORIDE 25MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

15G/50G

Recepto tipas:

OTC

Gydymo sritis:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Produkto santrauka:

Active ingredient group (AIG) number: 0252788001; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2013-02-14

Prekės savybės

_ _
_GlaxoSmithKline Consumer Healthcare Inc. _
_Page 1 of 44_
PRODUCT MONOGRAPH
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ADVIL COLD, COUGH & FLU NIGHTTIME
Ibuprofen 200 mg and Diphenhydramine Hydrochloride 25 mg Capsules
Analgesic/Antipyretic and Antihistamine/Antitussive
GlaxoSmithKline Consumer Healthcare Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Preparation:
January 29, 2013
Date of Revision:
May 5, 2020
Submission Control No: 237365
_ _
_GlaxoSmithKline Consumer Healthcare Inc. _
_Page 2 of 44_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................19
DOSAGE AND ADMINISTRATION
..............................................................................23
OVERDOSAGE
................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................25
STORAGE AND STABILITY
..........................................................................................28
SPECIAL HANDLING INSTRUCTIONS
.......................................................................28
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................28
PART II: SCIENTIFIC INFORMATION ...................................................................29
PHARMACEUTICAL INFORMATION