ADVIL PAIN & HEAD COLD NIGHT TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

DIPHENHYDRAMINE CITRATE; IBUPROFEN

から入手可能:

GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC

ATCコード:

M01AE51

INN（国際名）:

IBUPROFEN, COMBINATIONS

投薬量:

38MG; 200MG

医薬品形態:

TABLET

構図:

DIPHENHYDRAMINE CITRATE 38MG; IBUPROFEN 200MG

投与経路:

ORAL

パッケージ内のユニット:

10/20/40/72/80/180

処方タイプ:

OTC

治療領域:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

製品概要:

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

認証ステータス:

CANCELLED PRE MARKET

承認日:

2024-01-15

製品の特徴

_ _
_Pfizer Consumer Healthcare, a division of Pfizer Canada ULC _
_Page 1 of 54_
PRODUCT MONOGRAPH
_ _
ADVIL COLD & FLU
ADVIL PAIN & HEAD COLD NIGHT
Ibuprofen and Diphenhydramine Citrate Caplets
200 mg/38 mg
Analgesic/Antipyretic and Antihistamine
Pfizer Consumer Healthcare, a division of Pfizer Canada
ULC
450-55 Standish Court
Mississauga, Ontario
Canada L5R 4B2
Date of Revision:
October 16, 2019
Submission Control No.: 231035
_ _
_Pfizer Consumer Healthcare, a division of Pfizer Canada ULC _
_Page 2 of 54_
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
.................................................................................................