COLD AND SINUS PLUS TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Mevcut itibaren:

MARCAN PHARMACEUTICALS INC

ATC kodu:

M01AE51

INN (International Adı):

IBUPROFEN, COMBINATIONS

Doz:

2MG; 200MG; 30MG

Farmasötik formu:

TABLET

Kompozisyon:

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

Uygulama yolu:

ORAL

Paketteki üniteler:

10/20/24/40/72/100

Reçete türü:

OTC

Terapötik alanı:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2016-09-27

Ürün özellikleri

1 | P a g e
PRODUCT MONOGRAPH
COLD AND SINUS PLUS
Ibuprofen 200 mg, Pseudoephedrine Hydrochloride 30 mg and
Chlorpheniramine
Maleate 2 mg
Tablets
Analgesic/Antipyretic/Nasal Decongestant/Antihistamine
Date of Preparation:
September 27, 2016
Marcan Pharmaceuticals Inc.
77 Auriga Drive, Unit # 4
Ottawa, Ontario
K2E 7Z7
Submission Control No.: 197591
2 | P a g e
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
...........................................................................................................................
11
DRUG INTERACTIONS
............................................................................................................................
20
DOSAGE AND ADMINISTRATION
........................................................................................................
24
OVERDOSAGE
..........................................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
......................................................................................
27
STORAGE AND STABILITY
....................................................................................................................
33
SPECIAL HANDLING INSTRUCTIONS
.................................................................................................
33
DOSAGE FORMS, COMPOSITIO