Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections
Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections
The study is designed to meet regulatory requirement outside the US. The dosing regimen and
 assessments timepoints were dictated by immediate release (IR) guaifenesin (GGE) and do not
 match approved Mucinex labeling in the U.S. The purpose of this study is to determine whether
 Mucinex is effective and non-inferior as compared to placebo and immediate release
 guaifenesin in the treatment of symptoms of acute upper respiratory infections. This design
 was required based on EU regulatory guidance.
Inclusion Criteria:

 1. Has developed cold symptoms within 3 days prior to dosing on Day 1.

 Exclusion Criteria:

 1. Chronic illnesses.

 2. Febrile illness > 101 F within 7 days prior to Day 1,

 3. Pregnant.

 4. Known current malignancy.