IBUPROFEN DAYTIME, IBUPROFEN NIGHTTIME CAPSULE

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

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

可用日期:

VITA HEALTH PRODUCTS INC

ATC代码:

M01AE51

INN（国际名称）:

IBUPROFEN, COMBINATIONS

剂量:

25MG; 200MG; 200MG

药物剂型:

CAPSULE

组成:

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

给药途径:

ORAL

每包单位数:

DAYTIME 12/24 - NIGHTTIME 6/12

处方类型:

OTC

治疗领域:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

產品總結:

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

授权状态:

APPROVED

授权日期:

2015-02-16

产品特点

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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
..............................