Medicines

 

Medsafe Product Detail

File ref: TT50-0415/3
Trade NameDose FormStrengthIdentifier
Mylanta Double StrengthOral suspension.
SponsorApplication dateRegistration situationClassification
Johnson & Johnson (New Zealand) Limited
P O Box 62-185
Sylvia Park
Auckland 1644
31/7/1979Consent given
Approval date: 31/7/1979
General sale
 

Composition

ComponentIngredientManufacturer
oral suspensionActive 
 Aluminium hydroxide 80 mg/mL (added as aluminium / magnesium Co-Gel C655)SRL Pharma GmbH
Giulinistrasse 2
Ludwigshafen D-67065
Germany
 Magnesium hydroxide 80 mg/mL (added as aluminium / magnesium Co-Gel C655)SRL Pharma GmbH
Giulinistrasse 2
Ludwigshafen D-67065
Germany
 Simeticone 6 mg/mL (added as mg/mL of simethicone emulsion 30%)Dow Silicones Corporation
1635 North Gleaner Road
Hemlock
Michigan 48626
United States of America
 Excipient 
 Acesulfame potassium
 Butyl hydroxybenzoate
 Enhancer flavour FADP925 (natural sweetness)
 Ethanol
 Ethyl hydroxybenzoate
 Mint flavour SN011397
 Propyl hydroxybenzoate
 Purified water
 Sorbitol
 Xanthan gum
 Xylitol

Production

Manufacturing stepManufacturer
Finished Product TestingAMS Laboratories Pty Ltd
8 Rachael Close
Silverwater
NSW 2128
Australia
 Ensign Laboratories Pty Limited
490-500 Wellington Road
Mulgrave
VIC 3170
Australia
Manufacture of Final Dose FormEnsign Laboratories Pty Limited
490-500 Wellington Road
Mulgrave
VIC 3170
Australia
PackingEnsign Laboratories Pty Limited
490-500 Wellington Road
Mulgrave
VIC 3170
Australia
NZ Site of Product ReleaseJohnson & Johnson (New Zealand) Limited
507 Mt. Wellington Highway
Mt. Wellington
Auckland 1060

Packaging

PackageContentsShelf Life
Bottle, plastic, HDPE 200 mL18 months from date of manufacture stored at or below 30°C
Bottle, plastic, HDPE 500 mL18 months from date of manufacture stored at or below 30°C

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
19/2/2016Self-Assessable Change NotificationLabelling - Grade 1 (Self assessable)Notified23/2/2016