IBUPROFEN DAYTIME, IBUPROFEN NIGHTTIME CAPSULE

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

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

Mevcut itibaren:

VITA HEALTH PRODUCTS INC

ATC kodu:

M01AE51

INN (International Adı):

IBUPROFEN, COMBINATIONS

Doz:

25MG; 200MG; 200MG

Farmasötik formu:

CAPSULE

Kompozisyon:

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

Uygulama yolu:

ORAL

Paketteki üniteler:

DAYTIME 12/24 - NIGHTTIME 6/12

Reçete türü:

OTC

Terapötik alanı:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2015-02-16

Ürün özellikleri

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