Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media

Inclusion Criteria: * Male and female children between 6 months and 4 years of age * Weight does not exceed 40 kg * Clinical diagnosis is acute otitis media * Have evidence of middle ear fluid * At risk for persistent or recurrent otitis media * Generally in good health Exclusion Criteria: * Sensitivity or allergy to penicillins or cephalosporins or inability to take oral medications * Presence of tympanostomy tubes, ventilation tube or perforated tympanic membrane, in either ear * Treatment with any anti-infective agent within 3 days prior to the study or treatment with a long-acting injectable antimicrobial agent (e.g. , penicillin G benzathine) within 4 weeks prior to the study * Concomitant infection, that requires additional antimicrobial therapy * Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the patient's therapeutic response