GRAVOL CHEWABLES TABLET (CHEWABLE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
29-01-2016
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Active ingredient:
DIMENHYDRINATE
Available from:
CHURCH & DWIGHT CANADA CORP
ATC code:
R06AA11
INN (International Name):
DIMENHYDRINATE
Dosage:
50MG
Pharmaceutical form:
TABLET (CHEWABLE)
Composition:
DIMENHYDRINATE 50MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
OTC
Therapeutic area:
ANTIHISTAMINES
Product summary:
Active ingredient group (AIG) number: 0102747004; AHFS:
Authorization status:
APPROVED
Authorization date:
2020-02-13
Summary of Product characteristics
PRODUCT MONOGRAPH
GRAVOL
™
(Dimenhydrinate)
GRAVOL IM (CHURCH & DWIGHT STD.) 50 MG/ML
GRAVOL KIDS QUICK DISSOLVE CHEWABLE TABLETS 15 MG
GRAVOL QUICK DISSOLVE CHEWABLE TABLETS 50 MG
GRAVOL EASY TO SWALLOW TABLETS 50 MG
GRAVOL IMMEDIATE RELEASE & LONG ACTING CAPLET 100 MG
GRAVOL TASTEFREE LIQUID GEL CAPSULES 50 MG
GRAVOL COMFORT SHAPED SUPPOSITORIES 100 MG
GRAVOL KIDS COMFORT SHAPED SUPPOSITORIES 25 MG
GRAVOL KIDS LIQUID 15MG/5 ML
Antiemetic
CHURCH & DWIGHT CANADA CORP.
Date of Preparation: August 29, 1997
HEAD OFFICE
Date of Revision: January 25, 2016
635 Secretariat Court
Mississauga, ON
L5S 0A5
MANUFACTURING-MEDICAL-REGULATORY
5485 Ferrier Montreal, QC H4P 1M6
SUBMISSION CONTROL NUMBER: 188084
GRAVOL® Product Monograph
Page 2 of 25
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
3
SUMMARY PRODUCT INFORMATION
..............................................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................................
4
CONTRAINDICATIONS
.........................................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................................
4
ADVERSE REACTIONS
.........................................................................................................................
7
DRUG INTERACTIONS
.........................................................................................................................
8
DOSAGE AND ADMINISTRATION
.....................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
10
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................................................
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