COLD + SINUS TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Beli sekarang

Ciri produk Ciri produk (SPC)
01-09-2020

Bahan aktif:

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Boleh didapati daripada:

VITA HEALTH PRODUCTS INC

Kod ATC:

M01AE51

INN (Nama Antarabangsa):

IBUPROFEN, COMBINATIONS

Dos:

200MG; 30MG

Borang farmaseutikal:

TABLET

Komposisi:

IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

10/20/40/50/72/96/100

Jenis preskripsi:

OTC

Kawasan terapeutik:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0222394001; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2010-06-08

Ciri produk

                                Vita Health Products Inc.
Page 1
of 49
PRODUCT MONOGRAPH
COLD + SINUS
Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP
Ibuprofen 200 mg, Pseudoephedrine Hydrochloride 30 mg
Caplets
Analgesic/Antipyretic/Nasal Decongestant
Vita Health Products Inc.
Date of Revision:
150 Beghin Avenue
September 1, 2020
Winnipeg, Manitoba Canada, R2J 3W2
Control No. 242681
Vita Health Products Inc.
Page 2
of 49
_ _
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
....................................................................................................................................
18
DOSAGE AND ADMINISTRATION
................................................................................................................
21
OVERDOSAGE
..................................................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
..............................................................................................
24
STORAGE AND STABILITY
...........................................................................................................................
28
SPECIAL HANDLING INSTRUCTION
..
                                
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