Generally healthy male or female children/adolescents ages 6 to 11 years. - Subject has an acute cough and other symptoms consistent with a common cold/acute upper respiratory tract infection (URTI) diagnosis as deemed by the investigator.
- The onset of symptoms must be no more than 3 days prior to Visit 1, as determined by the subject or parent/legally acceptable representative.
- Qualifying responses on study questionnaires.
- Parent/legally acceptable representative, and subject agrees the subject will not use any other cough or cold treatments during the study.
- Fever greater than 102ºF oral temperature at the time of screening.
- Diabetes or hypoglycemic disorders.
- Known or suspected allergies to the investigational product or acetaminophen (APAP).
- History of taking a medication that is sedating within the past 24 hours prior to
screening (eg sedatives, hypnotics, tranquilizers, anticonvulsants, benzodiazepines,
- Subject has a sibling participating at the same time in this study.
- Subjects must wear cough counting device for two hours and then return to the study site to complete screening procedures.
- Subjects whose equipment failed or those who took off the device during this period will be excluded from further study participation.
- Subjects who do not return to the study site (before 3:30 pm) in time for the afternoon dose will be excluded from further study participation.