Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-0415/3 |
| Trade Name | Dose Form | Strength | Identifier |
| Mylanta Double Strength | Oral suspension | . | |
| Sponsor | Application date | Registration situation | Classification |
| Johnson & Johnson (New Zealand) Limited P O Box 62-185 Sylvia Park Auckland 1644 | 31/7/1979 | Approval lapsed Approval date: 31/7/1979 Notification date: 22/7/2021 | General sale |
Composition
| Component | Ingredient | Manufacturer |
| oral suspension | Active | |
| 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 step | Manufacturer |
| Finished Product Testing | AMS 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 Form | Ensign Laboratories Pty Limited 490-500 Wellington Road Mulgrave VIC 3170 AUSTRALIA |
| Packing | Ensign Laboratories Pty Limited 490-500 Wellington Road Mulgrave VIC 3170 AUSTRALIA |
| NZ Site of Product Release | Johnson & Johnson (New Zealand) Limited 507 Mt. Wellington Highway Mt. Wellington Auckland 1060 |
Packaging
| Package | Contents | Shelf Life |
| Bottle, plastic, HDPE | 200 mL | 18 months from date of manufacture stored at or below 30°C |
| Bottle, plastic, HDPE | 500 mL | 18 months from date of manufacture stored at or below 30°C |
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 19/2/2016 | Self-Assessable Change Notification | Labelling - Grade 1 (Self assessable) | Notified | 23/2/2016 |
