Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-1864/3
Trade NameDose FormStrengthIdentifier
Orthoxicol Dry Cough Mixture (with Paracetamol)Syrup.
SponsorApplication dateRegistration situationClassification
Johnson & Johnson (New Zealand) Limited
P O Box 9222
Newmarket
Auckland 1149
11/1/1993Approval lapsed
Approval date: 27/5/1993
Notification date: 16/10/2001
Pharmacy only
 

Composition

ComponentIngredientManufacturer
syrupActive 
 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/mLSpecGx 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 stepManufacturer
Manufacture of Final Dose FormAspen 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
PackingAspen 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 ReleaseNo site specified

Packaging

PackageContentsShelf Life
Bottle, glass, 1x100ml100 mL36 months from date of manufacture stored at or below 30°C
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