Medicines

 

Medsafe Product Detail

File ref: TT50-0415/4
Trade NameDose FormStrengthIdentifier
Mylanta POral suspension.
SponsorApplication dateRegistration situationClassification
Johnson & Johnson (New Zealand) Limited
P O Box 62-185
Sylvia Park
Auckland 1644
11/4/2001Not available
Approval date: 26/7/2001
Notification date: 9/11/2018
General sale
 

Composition

ComponentIngredientManufacturer
oral suspensionActive 
 Aluminium hydroxide 40 mg/mL (added as (10.85% AlOH dried ) aluminium / magnesium Co-Gel C655, 9.4% overage)SRL Pharma GmbH
Giulinistrasse 2
Ludwigshafen D-67065
Germany
 Magnesium hydroxide 40 mg/mL (added as (10.85% MgOH dried ) aluminium / magnesium Co-Gel C655 9.4% overage)SRL Pharma GmbH
Giulinistrasse 2
Ludwigshafen D-67065
Germany
 Simeticone 4 mg/mL (added as 13.3 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 TestingEnsign 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 bottles500 mL18 months from date of manufacture stored at or below 30°C
6 months opened stored at 2° to 8°C (Refrigerate, do not freeze)

Indications

Relief from indigestion, heartburn, upset stomach, flatulence and wind pain.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
12/11/2015Changed Medicine NotificationActive ingredient manufacturing process - Grade 1; Administrative fee (CMN)Granted 27/11/201517/11/2015