Efficacy of Diclofenac Potassium Versus Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections

Inclusion Criteria: * Male and female outpatients, aged 2 to 6 years presenting tympanic temperature ≥ 38.5 ° C and no greater than 39.5° C, associated with acute upper respiratory tract infections * Parents or legal representatives who have provided written informed consent and provided a phone number for the call at end of study Exclusion Criteria: * History of hypersensitivity to any drugs or excipients of the study * Any medication, surgical, or medical condition, which might significantly alter the absorption, distribution, metabolism, or excretion of medications * Background or suspected hematological disorders, febrile seizures, asthma, peptic ulcer or gastrointestinal bleeding * Neurological and hemodynamics disorders * Evidence of liver or kidney impairment or heart failure * Patients who have received previous treatment with antipyretics; acetaminophen (up to 4 hrs), NSAIDs (up to 6 hrs) or antibiotic therapy (at least 12 hours) * Any surgical or medical condition, which in the opinion of the investigator, may place the patient at risk Other protocol-defined inclusion/exclusion criteria may apply