NUROFEN FOR CHILDREN 7+ YEARS Orange Flavour ibuprofen 100 mg soft chewable capsules blister pack, Reckitt Benckiser Pty Ltd, CON-1113
Product name
NUROFEN FOR CHILDREN 7+ YEARS Orange Flavour ibuprofen 100 mg soft chewable capsules blister pack
Sponsor name
Reckitt Benckiser Pty Ltd
Batches
NB589, NM026, NN307, NN313
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