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PRODUCT MONOGRAPH GRAVOL

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.

Parental / 50 mg per 1 mL vial 50% propylene glycol, water for injection, hydrochloric acid and sodium hydroxide for pH adjustment GRAVOL Immediate Release & Long Acting Caplets Oral Caplets / 100 mg total dimenhydrinate: 25 mg dimenhydrinate for immediate release and 75 mg dimenhydrinate for sustained release.

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