ADVIL COLD AND SINUS NIGHTTIME TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE

제공처:

GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC

ATC 코드:

M01AE51

INN (International Name):

IBUPROFEN, COMBINATIONS

복용량:

200MG; 30MG; 2MG

약제 형태:

TABLET

구성:

IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG; CHLORPHENIRAMINE MALEATE 2MG

관리 경로:

ORAL

패키지 단위:

6/10/12/20/40/72

처방전 유형:

OTC

치료 영역:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

제품 요약:

Active ingredient group (AIG) number: 0349765001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2010-12-08

제품 특성 요약

_ _
_GlaxoSmithKline Consumer Healthcare Inc. _
_Page 1 of 67_
PRODUCT MONOGRAPH
ADVIL COLD & SINUS NIGHTTIME
Ibuprofen, Pseudoephedrine Hydrochloride
and Chlorpheniramine Maleate Caplets
200 mg/30 mg/2 mg
Analgesic/Antipyretic/Nasal Decongestant/Antihistamine
GlaxoSmithKline Consumer Healthcare Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Preparation:
June 13, 2006
Revised: April 3, 2020
Submission Control No: 237320
_ _
_GlaxoSmithKline Consumer Healthcare Inc. _
_Page 2 of 67_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................21
DOSAGE AND ADMINISTRATION
..............................................................................26
OVERDOSAGE
................................................................................................................26
ACTION AND CLINICAL PHARMACOLOGY
............................................................30
STORAGE AND STABILITY
..........................................................................................34
SPECIAL HANDLING INSTRUCTIONS
.......................................................................34
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................34
PART II: SCIENTIFIC INFORMATION
...............................................................................35