Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-1864/3 |
| Trade Name | Dose Form | Strength | Identifier |
| Orthoxicol Dry Cough Mixture (with Paracetamol) | Syrup | . | |
| Sponsor | Application date | Registration situation | Classification |
| Johnson & Johnson (New Zealand) Limited P O Box 9222 Newmarket Auckland 1149 | 11/1/1993 | Approval lapsed Approval date: 27/5/1993 Notification date: 16/10/2001 | Pharmacy only |
Composition
| Component | Ingredient | Manufacturer |
| syrup | Active | |
| Dextromethorphan hydrobromide monohydrate 2 mg/mL (2.06mg/ml with manufacturers 3% overage.) | F Hoffmann-La Roche Ltd Grenzacherstrasse 124 Basel CH-4070 SWITZERLAND | |
| Paracetamol 50 mg/mL | SpecGx LLC 8801 Capital Boulevard Raleigh North Carolina 27616-3116 UNITED STATES OF AMERICA | |
| Excipient | ||
| Allura red AC | ||
| Citric acid monohydrate | ||
| Macrogol 400 | ||
| Menthol | ||
| Purified water | ||
| Raspberry | ||
| Saccharin sodium | ||
| Sodium citrate dihydrate | ||
| Sorbitol |
Production
| Manufacturing step | Manufacturer |
| Manufacture of Final Dose Form | Aspen Pharma Pty Ltd (Creams and liquids man. site) 1408 Centre Road Clayton VIC 3168 AUSTRALIA |
| Pharmacia Australia Pty Limited 59 Kirby Street Rydalmere NSW 2116 AUSTRALIA | |
| Packing | Aspen Pharma Pty Ltd (Creams and liquids man. site) 1408 Centre Road Clayton VIC 3168 AUSTRALIA |
| Pharmacia Australia Pty Limited 59 Kirby Street Rydalmere NSW 2116 AUSTRALIA | |
| NZ Site of Product Release | No site specified |
Packaging
| Package | Contents | Shelf Life |
| Bottle, glass, 1x100ml | 100 mL | 36 months from date of manufacture stored at or below 30°C |
