NIGHTTIME PAIN RELIEVER CAPSULE
国家: 加拿大
语言: 英文
来源: Health Canada
产品特点
(SPC)
06-10-2016
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有效成分:
IBUPROFEN; DIPHENHYDRAMINE HYDROCHLORIDE
可用日期:
MARCAN PHARMACEUTICALS INC
ATC代码:
M01AE51
INN（国际名称）:
IBUPROFEN, COMBINATIONS
剂量:
200MG; 25MG
药物剂型:
CAPSULE
组成:
IBUPROFEN 200MG; DIPHENHYDRAMINE HYDROCHLORIDE 25MG
给药途径:
ORAL
每包单位数:
10/40/100
处方类型:
OTC
治疗领域:
ETHANOLAMINE DERIVATIVES
產品總結:
Active ingredient group (AIG) number: 0252788001; AHFS:
授权状态:
CANCELLED PRE MARKET
授权日期:
2021-05-13
产品特点
Page 1 of 52
PRODUCT MONOGRAPH
NIGHTTIME PAIN RELIEVER
Ibuprofen and Diphenhydramine Hydrochloride Liquid Gel Capsules
Ibuprofen 200mg and Diphenhydramine Hydrochloride 25mg
Analgesic/Sleep Aid
Date of Revision:
September 13, 2016
Marcan Pharmaceuticals Inc.
77 Auriga Drive, Unit# 4,
Ottawa, Ontario
K2E 7Z7
CONTROL# 197397
Page 2 of 52
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................................
3
SUMMARY PRODUCT INFORMATION
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3
INDICATIONS AND CLINICAL USE
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3
CONTRAINDICATIONS
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3
WARNINGS AND PRECAUTIONS
.......................................................................................................
4
ADVERSE REACTIONS
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10
DRUG INTERACTIONS
........................................................................................................................
17
DOSAGE AND ADMINISTRATION
....................................................................................................
21
OVERDOSAGE
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21
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
23
STORAGE AND STABILITY
...............................................................................................................
26
SPECIAL HANDLING INSTRUCTIONS
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26
DOSAGE FORMS, COMPOSITION AND PACKAGING
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