Conditions: Healthy Subjects
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 552
Healthy volunteers: yes

Brief summary:
This was an open label, multicentric, non-comparative, single arm prospective post marketing surveillance (PMS) study to evaluate the safety and tolerability of Mucinex™ (GGE, 600 mg ER bi-layer tablets, taken as 1200 mg BID dose) in the treatment of otherwise healthy patients with symptoms of cough, thickened mucus and chest congestion due to URTI. Symptomatic patients who visited the outpatient department of hospitals and clinics or general physicians and had agreed to participate in this study were screened and enrolled into the study.

Detailed description:

Arms:
arm 1: 2 tablets of Mucinex™ (GGE, 600 mg ER bi-layer tablets, taken as 1200 mg BID dose) every 12 hours (twice daily, in the morning and the evening) orally with a full glass of water for 7 days.

GGE = Guaifenesin

BID = Twice in a day

Interventions: intervention 1: Mucinex™ extended-release (SE)
Intervention descriptions: intervention 1: 2 tablets of Mucinex™ (GGE, 600 mg extended-release bi-layer tablets)

Protocol document: