Study to Evaluate the Pharmacokinetics of Guaifenesin in Adults and Adolescents

Inclusion Criteria

• Males and females ≥ 12 and 40 miU/mL must have been obtained and in the record for any post-menopausal female experiencing their last menses 5th percentile and less than the 95th percentile for weight and BMI of ≥ 18 to ≤ 28 kg/m2 based on age and gender.
• Non-tobacco users, who had not used nicotine or nicotine-containing products for at least 1 year prior to Day 1 of Period 1.
• Negative finding on tests for hepatitis B surface antigen (HBsAG), hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV).
• Negative urine screen for drugs of abuse and alcohol at Screening and each Check-in.
• Likely to be compliant and complete the study, and if 4 infections per year for adolescents aged ≥ 12 to ) 4 persons living in the home or > 3 persons sleeping in one bedroom.

Exclusion Criteria

• Clinically significant abnormalities detected by medical history, physical examination, vital sign measurements, ECG findings, or clinical laboratory findings (as determined by the PI), including a hemoglobin value < 12 gm/dL at Screening.
• Females who were pregnant or nursing.
• History of hypersensitivity reaction to guaifenesin or to EMLA® cream (eutectic mixture of local anesthetic) or its components (lidocaine + prilocaine as local anesthetic).
• Receipt of an investigational drug within 30 days prior to Day 1 of Period 1.
• Abnormal diet (for whatever reason) during the 30 days prior to Day 1 of Period 1.
• Donation of blood or significant loss of blood within 56 days prior to Day 1 of Period 1.
• Donation of plasma within 14 days prior to Day 1 of Period 1.
• Known or suspected use of illicit drugs (i.e., opiates, barbiturates, marijuana, et. al.).
• The use of any medication on a chronic basis, with the exception of hormonal contraceptives for women of child-bearing potential. An appropriate drug free period for prescription or OTC drugs should have been provided to wash out any especially long half-life drugs.
• Alcoholism or medicinal product or drug abuse within the past two years or excessive alcohol consumption (more than 10 units per week) (one unit was defined as 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of spirits (i.e., "hard" liquor such as gin, whiskey, or vodka, et. al.). The subject was not to experience tolerance, withdrawal, compulsive use, or substance related problems such as medical complications, disruption in social and family relationships, vocational or financial difficulties, or legal problems.
• Consumption of grapefruit, pummelo, Seville orange or grapefruit juice within 14 days prior to dosing with study medication. Subjects had to be willing to abstain from consuming any of these products during the study.
• Related to persons involved directly or indirectly with the conduct of this study (i.e., PI, Sub-Investigators, Study Coordinators, other study personnel, employees of Reckitt Benckiser, and the families of each).

Subject Exclusion Criteria at Check-In

• Any significant change from Screening in medical history, medication history, alcohol consumption, or tobacco/nicotine use, in the opinion of the PI.
• Reports any known enzyme-inducer, enzyme-inhibitor, or reported chronic exposure to enzyme-inducers such as paint solvents or pesticides since Screening, unless approved by Reckitt Benckiser.
• Reports any other prescription or OTC drug or herbal remedy since Screening (except for low-dose contraceptives, multivitamins, and/or fluoride supplements) unless allowed by Reckitt Benckiser.
• If female, a positive urine pregnancy test.
• Had an acute illness since Screening, unless allowed by Reckitt Benckiser.