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Guaifenesin

Generic Name
Guaifenesin
Brand Names
Broncotron, Bronkaid, Cheracol D, Cheratussin, Cheratussin Dac, Codar Gf, Coricidin Hbp Chest Congestion, DM, Deconex, Delsym Cough Plus Chest Congestion DM, Despec Reformulated Jun 2008, Diabetic Tussin DM, Diabetic Tussin EX, Diphen, Entex Lq, Entex T, G-zyncof, Gilphex, M-clear Wc, Mar-cof Cg, Mucinex, Mucinex Children's Cough, Mucinex Cough, Mucinex D, Mucinex DM, Mucinex Stuffy Nose & Cold, Ninjacof Xg, Obredon, Pediacare Children's Cough and Congestion, Refenesen, Refenesen PE, Rescon-GG, Robafen, Robafen DM, Robitussin Chest Congestion, Robitussin Cough & Congestion, Robitussin Maximum Strength Cough Plus Chest Congestion DM, Safetussin DM, Scot-tussin, Scot-tussin DM, Siltussin, Tusnel C, Tusnel Diabetic
Drug Type
Small Molecule
Chemical Formula
C10H14O4
CAS Number
93-14-1
Unique Ingredient Identifier
495W7451VQ
Background

Guaifenesin possesses a storied history, having been originally formally approved by the US FDA in 1952 and continues to be one of very few - if not perhaps the only drug that is readily available and used as an expectorant . Since that time the agent has been a combination component of various prescription and non-prescription over-the-counter cough and cold products and is currently a widely available over-the-counter generic medication . Although it is principally believed that guaifenesin elicits an action to facilitate productive cough to manage chest congestion , it is not known whether the agent can reliably mitigate coughing.

Regardless, on March 1, 2007, the FDA received a petition asking the FDA to notify the public that some antitussives, expectorants, decongestants, antihistamines, and cough/cold combinations are not known to be safe and effective in children under the age of 6 years . After the negotiation between FDA and major manufacturers, a voluntary transition of labels for not using guaifenesin in children under the age of 4 years was endorsed by FDA in 2008 .

Furthermore, there has also been contemporary research to suggest that guaifenesin possesses and is capable of demonstrating anticonvulsant and muscle relaxant effects to some degree possibly by acting as an NMDA receptor antagonist .

Indication

Guaifenesin is an expectorant that is indicated for providing temporary symptomatic relief from congested chests and coughs which may be due to a cold, bronchitis, and/or other breathing illnesses .

Associated Conditions
Allergic Reaction, Allergy to Tree Pollen, Asthma, Asthma, Allergic, Bronchial Asthma, Bronchitis, Bronchospasm, Chronic Bronchitis, Chronic Obstructive Pulmonary Disease (COPD), Common Cold, Cough, Cough caused by Common Cold, Coughing caused by Allergies, Coughing caused by Flu caused by Influenza, Drug Allergy, Emphysema, Fever, Flu caused by Influenza, Food Allergy, Headache, House dust allergy, Irritative cough, Laryngitis, Nasal Congestion, Nasal Congestion caused by Common Cold, Phlegm, Productive cough, Rash, Rhinorrhoea, Sneezing, Sore Throat, Tracheitis, Urticaria, Whooping Cough, Acute Rhinitis, Chest congestion, Chills occurring with fever, Dry cough, Excess mucus or phlegm, Mild to moderate pain, Minor aches and pains
Associated Therapies
Airway secretion clearance therapy, Expectorant

Bioequivalence Study of Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg Under Fasting Conditions

First Posted Date
2018-10-15
Last Posted Date
2018-10-15
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
80
Registration Number
NCT03706300
Locations
🇮🇳

QPS Bioserve India Pvt. Limited, Hyderabad, Telangana, India

Mucinex® ER 600 mg Bi-Layer Tablet Fed and Fasted

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
First Posted Date
2018-08-28
Last Posted Date
2019-03-27
Lead Sponsor
Reckitt Benckiser LLC
Target Recruit Count
36
Registration Number
NCT03649750

Study to Evaluate the Pharmacokinetics of Mucinex 600 mg Extended-release Bi-layer Tablet in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
First Posted Date
2018-08-23
Last Posted Date
2019-02-28
Lead Sponsor
Reckitt Benckiser Inc.
Target Recruit Count
30
Registration Number
NCT03644108

Bioequivalence Study Comparing Mucinex Extended-release 600 mg Tablets to Immediate-release Guaifenesin 600 mg in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
Drug: Vicks Cough Syrup for Chesty Coughs
First Posted Date
2018-08-23
Last Posted Date
2019-06-19
Lead Sponsor
Reckitt Benckiser Inc.
Target Recruit Count
30
Registration Number
NCT03644095

Mucinex® ER 600 mg Bi-layer Tablet Versus Guaifenesin Immediate Release (IR) 200 mg q4h

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
First Posted Date
2018-08-22
Last Posted Date
2019-06-17
Lead Sponsor
Reckitt Benckiser Inc.
Target Recruit Count
30
Registration Number
NCT03642262

Study to Evaluate the Pharmacokinetics of Mucinex® 1200 mg Extended-Release Tablet

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
First Posted Date
2018-08-16
Last Posted Date
2019-02-28
Lead Sponsor
Reckitt Benckiser LLC
Target Recruit Count
24
Registration Number
NCT03633487

A Bioequivalence Study Between Two Brands of Medications to Treat Cough & Cold Symptoms

Phase 1
Completed
Conditions
Bioequivalence
Healthy Volunteers
Interventions
Drug: Vicks Active SymptoMax Plus powder for oral solution
First Posted Date
2017-07-11
Last Posted Date
2018-07-06
Lead Sponsor
Johnson & Johnson Consumer and Personal Products Worldwide
Target Recruit Count
72
Registration Number
NCT03213353
Locations
🇷🇺

Scientific Research center Eco-Safety LLC, Saint Petersburg, Russian Federation

A Non-Interventional Safety Study of Balsamic Bactrim

Completed
Conditions
Bronchitis
Interventions
First Posted Date
2016-09-16
Last Posted Date
2017-11-07
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
52
Registration Number
NCT02902640
Locations
🇵🇪

Clinica San Borja; Instituto de Enfermedades Respiratorias EFEH, Lima, Peru

🇵🇪

Clinica de Especialidades Medicas, Lima, Peru

🇵🇪

Centro de Investigaciones Medicas/Hospital Maria Auxiliadora, San Juan de Miraflores, Peru

and more 1 locations

A Safety Study of Balsamic Bactrim in Pediatric Participants With Acute Bronchitis

Completed
Conditions
Bronchitis
Interventions
First Posted Date
2016-08-26
Last Posted Date
2019-12-13
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
51
Registration Number
NCT02879981
Locations
🇵🇪

Hospital Emergencias Pediatricas; Unidad de Investigación Pediátrica, La Victoria, Peru

🇵🇪

Clínica Anglo Americana-CENTRO DE INVESTIGACION PEDIATRIA CAA, San Isidro, Peru

🇵🇪

Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional, Lima, Peru

Mucinex® for Treatment of Filamentary Keratitis

Not Applicable
Completed
Conditions
Filamentary Keratitis
Interventions
First Posted Date
2016-08-09
Last Posted Date
2020-02-19
Lead Sponsor
Massachusetts Eye and Ear Infirmary
Target Recruit Count
15
Registration Number
NCT02859246
Locations
🇺🇸

Massachusetts Eye and Ear Infirmary, Boston, Massachusetts, United States

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