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2014-12-17 14:59:04 · Revision 1

Montelukast 5 mg Chewable Tablets - error on the carton

(Mylan) Carton incorrectly states "For children 2 to 5 years" but patient information leaflet (PIL) correctly states "For children 6 to 14 years" – class 2 action within 48 hours. (EL (13)A/08)

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Source: Medicines and Healthcare products Regulatory Agency (MHRA). Read the full notice, including its required actions and deadlines, before recording your response.