ADVIL COLD & SINUS CONVENIENCE PACK KIT
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
27-10-2020
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
Available from:
GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC
ATC code:
M01AE51
INN (International Name):
IBUPROFEN, COMBINATIONS
Dosage:
200MG; 30MG; 200MG; 30MG; 2MG
Pharmaceutical form:
KIT
Composition:
IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG; IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG; CHLORPHENIRAMINE MALEATE 2MG
Administration route:
ORAL
Units in package:
18/36
Prescription type:
OTC
Therapeutic area:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0553187001; AHFS:
Authorization status:
APPROVED
Authorization date:
2020-11-12
Summary of Product characteristics
_ _
_GlaxoSmithKline Consumer Healthcare Inc. _
_Page 1 of 72_
PRODUCT MONOGRAPH
ADVIL COLD & SINUS CONVENIENCE PACK
ADVIL COLD & SINUS DAYTIME
Ibuprofen and Pseudoephedrine
Hydrochloride Tablets USP
200 mg/30 mg
Analgesic/Antipyretic/Nasal Decongestant
ADVIL COLD & SINUS NIGHTTIME
Ibuprofen, Pseudoephedrine Hydrochloride
and Chlorpheniramine Maleate Caplets
200 mg/30 mg/2 mg
Analgesic/Antipyretic/Nasal
Decongestant/Antihistamine
GlaxoSmithKline Consumer Healthcare ULC
7333 Mississauga Road, Mississauga, Ontario
L5N 6L4
Date of Preparation:
January 8, 2013
Revised : October 27, 2020
Submission Control No: 240564
_ _
_GlaxoSmithKline Consumer Healthcare Inc. _
_Page 2 of 72_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................14
DRUG INTERACTIONS
..................................................................................................24
DOSAGE AND ADMINISTRATION
..............................................................................29
OVERDOSAGE
................................................................................................................29
ACTION AND CLINICAL PHARMACOLOGY
............................................................33
STORAGE AND STABILITY
..........................................................................................37
SPECIAL HANDLING INSTRUCTIONS
.......................................................................37
DOSAGE FORMS, COMPOSITI
Read the complete document
