IBUPROFEN + PSEUDOEPHEDRINE CAPLETS TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Saatavilla:

MARCAN PHARMACEUTICALS INC

ATC-koodi:

M01AE51

INN (Kansainvälinen yleisnimi):

IBUPROFEN, COMBINATIONS

Annos:

200MG; 30MG

Lääkemuoto:

TABLET

Koostumus:

IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG

Antoreitti:

ORAL

Kpl paketissa:

10/24/100

Prescription tyyppi:

OTC

Terapeuttinen alue:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2016-08-23

Valmisteyhteenveto

Page 1 of 47
PRODUCT MONOGRAPH
IBUPROFEN + PSEUDOEPHEDRINE CAPLETS
Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP
Ibuprofen 200 mg, Pseudoephedrine Hydrochloride 30 mg
Caplets
Analgesic/Antipyretic/Nasal Decongestant
Marcan Pharmaceuticals Inc.
Date of Preparation:
77 Auriga Drive, Unit #4
August 23, 2016
Ottawa, Ontario
K2E 7Z7
Control# 197421
Page 2 of 47
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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
....................................................................................................................
10
DRUG INTERACTIONS
.....................................................................................................................
17
DOSAGE AND ADMINISTRATION
.................................................................................................
20
OVERDOSAGE
...................................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
...............................................................................
22
STORAGE AND STABILITY
............................................................................................................
26
SPECIAL HANDLING INSTRUCTION
............................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................................