IBUPROFEN DAYTIME, IBUPROFEN NIGHTTIME CAPSULE

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN (IBUPROFEN, IBUPROFEN POTASSIUM); IBUPROFEN (IBUPROFEN, IBUPROFEN POTASSIUM)

제공처:

VITA HEALTH PRODUCTS INC

ATC 코드:

M01AE51

INN (International Name):

IBUPROFEN, COMBINATIONS

복용량:

25MG; 200MG; 200MG

약제 형태:

CAPSULE

구성:

DIPHENHYDRAMINE HYDROCHLORIDE 25MG; IBUPROFEN (IBUPROFEN, IBUPROFEN POTASSIUM) 200MG; IBUPROFEN (IBUPROFEN, IBUPROFEN POTASSIUM) 200MG

관리 경로:

ORAL

패키지 단위:

DAYTIME 12/24 - NIGHTTIME 6/12

처방전 유형:

OTC

치료 영역:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

제품 요약:

Active ingredient group (AIG) number: 0354570001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2015-02-16

제품 특성 요약

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_Page 1 of 61_
PRODUCT MONOGRAPH
IBUPROFEN DAYTIME,
IBUPROFEN NIGHTTIME
(DAY/NIGHT CONVENIENCE PACK)
IBUPROFEN DAYTIME
Ibuprofen Liquid Capsules 200 mg
(free acid and potassium salt)
Analgesic
IBUPROFEN NIGHTTIME
Ibuprofen and Diphenhydramine Hydrochloride Liquid Gel Capsules
Ibuprofen 200 mg (free acid and potassium salt) and Diphenhydramine
Hydrochloride 25 mg
Analgesic/Sleep Aid
Vita Health Products Inc.
150 Beghin Avenue
Winnipeg Manitoba
Canada, R2J 3W2
Submission Control No. 180118
Date of Preparation:
January 30, 2015
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_Page 2 of 61_
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
...............................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 26
STORAGE AND STABILITY
.........................................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 29
PART II: SCIENTIFIC INFORMATION
..............................................................................
31
CLINICAL TRIALS
..............................