COLD + SINUS PLUS TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN; CHLORPHENIRAMINE MALEATE

Boleh didapati daripada:

VITA HEALTH PRODUCTS INC

Kod ATC:

M01AE51

INN (Nama Antarabangsa):

IBUPROFEN, COMBINATIONS

Dos:

30.0MG; 200.0MG; 2.0MG

Borang farmaseutikal:

TABLET

Komposisi:

PSEUDOEPHEDRINE HYDROCHLORIDE 30.0MG; IBUPROFEN 200.0MG; CHLORPHENIRAMINE MALEATE 2.0MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

10/20/24/72/100

Jenis preskripsi:

OTC

Kawasan terapeutik:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2010-11-29

Ciri produk

Page 1 of 69
PRODUCT MONOGRAPH
COLD + SINUS PLUS
Ibuprofen 200 mg, Pseudoephedrine Hydrochloride 30 mg
and Chlorpheniramine Maleate 2 mg Tablets
Analgesic/Antipyretic/Nasal Decongestant/Antihistamine
Vita Health Products Inc.
Date of Revision:
150 Beghin Avenue
September 16, 2020
Winnipeg, Manitoba Canada, R2J 3W2
Control No.: 238538
Page 2 of 69
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
................................................................................................
12
DRUG INTERACTIONS
................................................................................................
21
DOSAGE AND ADMINISTRATION
............................................................................
25
OVERDOSAGE
...............................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 29
STORAGE AND STABILITY
........................................................................................
35
SPECIAL HANDLING INSTRUCTIONS
......................................................................
35
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................ 35
PART II: SCIENTIFIC INFORMATION
................................................................................
36
PHARMACEUTICAL INFORMATION
........................................................................
36
CLINICAL TRIALS
........................................