SECTion 14 AND 14A NOTICE
I, MAYADA KAYALI, delegate of the Secretary to the Department of Health and Ageing for the purposes of sections 14, 14A and 15 of the Therapeutic Goods Act 1989 (‘the Act’) hereby give my consent, pursuant to sections 14 and 14A of the Act, for Johnson & Johnson Pacific Pty Ltd, 45 Jones Street, Ultimo, NSW 2007 to supply CODRAL RELIEF MUCUS COUGH guaiphenesin 20 mg/mL oral liquid bottle (AUST R 204221) and BENADRYL MUCUS RELIEF guaiphenesin 20 mg/mL oral liquid bottle (AUST R 204233) that do not comply with the requirements of the United States Pharmacopoeia monograph ‘Guaifenesin Oral Solution’ such that the pH range for CODRAL RELIEF MUCUS COUGH guaiphenesin 20 mg/mL oral liquid bottle (AUST R 204221) and BENADRYL MUCUS RELIEF guaiphenesin oral liquid bottle (AUST R 204233) is 4.2-5.0.
Pursuant to section 15(1) of the Act, my consent is subject to the following conditions:
- The product complies with all other aspects of the standard.
(Signed by)
Mayada Kayali
Delegate of the Secretary
Office of Medicines Authorisation
20 December 2012