This is a placebo-controlled, double-blind, randomized, parallel group pilot study in
approximately 150 subjects to evaluate the efficacy of dextromethorphan hydrobromide (DXM) on
acute cough in a pediatric population. Subjects will be otherwise healthy males and females
aged 6-11 inclusive who are experiencing acute cough as a symptom of common cold or upper
respiratory tract infection. Subjects must have had onset of symptoms within 3 days of
screening and qualify based on physical exam and symptom questionnaire. Eligible subjects
will be given a single-blind placebo, and fitted with a cough counting device for a 2 hour
run-in period. Qualifying subjects will be stratified by age and then randomized to either
DXM or placebo in a 1:1 ratio and fitted with the cough recording device for the first 24
hours of treatment. Subjects will receive approximately 9 doses of investigational product
over the course of the 4 day study and will complete patient reported outcome questions
before the morning and afternoon doses. Subjects will return to the study site on Day 2 to
remove the cough recorder and on Day 4 (+ 2 days) to complete the final visit. A review of
any reported adverse events will also be completed.