Male and female subjects who are 18 years old or older at the time of screening.
Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
Subjects must present with a score of 5 of higher for at least 2 of the following 6
symptoms: runny nose, plugged nose, sneezing, sore throat, scratchy throat, or head
congestion on the WURSS-21 assessment, within 36 hours of onset of symptoms.
Anyone with a history of chronic allergic rhinitis or asthma at the time of the screening
visit, or with history of chronic recurrent airway disease, infections, or frequent
complications of colds (otitis media, sinusitis, or bronchitis)
Subjects taking any prescription or non-prescription drug, within the last 7 days prior to
the screening, with which the administration of IBU, PE, CHLOR, or APAP is contraindicated,
may increase the risk associated with study participation, or may interfere with the
interpretation of study results, in the judgment of the Investigator.
Subjects currently taking a monoamine oxidase (MAO) inhibitor, or has taken an MAO
inhibitor within 2 months of screening.
Subjects currently taking a serotonin-selective reuptake inhibitor (SSRI), tricyclic
antidepressant (TCA), barbiturate, or any other neuroleptic, or has taken an SSRI, TCA,
barbiturate, or any other neuroleptic within 14 days of screening.
Subjects with a hypersensitivity to IBU, PE, or CHLOR or APAP.