NUROFEN ZAVANCE 256 mg ibuprofen sodium sugar coated tablet blister pack, Reckitt Benckiser Pty Ltd, CON-1113
Product name
NUROFEN ZAVANCE 256 mg ibuprofen sodium sugar coated tablet blister pack
Sponsor name
Reckitt Benckiser Pty Ltd
Batches
NR020, NR639, NB605, NM441, NN322, NX359
Consent start
Consent no.
CON-1113
Standard
paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines
Non-compliance with standard
The product labels display the RASML 5 advisory statements 'Unless a doctor has
told you to do not use in children under 7 years' or 'Unless a doctor has told
you to do not use in children under 12 years' instead of the advisory statements
required by RASML 6 'Do not use in children under 7 years' or 'Do not use in
children under 12 years', as relevant to the product.
Therapeutic product type
Over-the-counter medicines