MedPath

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

Effectiveness Study of Integrative Treatment for Pediatric Pneumonia

Not Applicable
Completed
Conditions
Pneumonia
Interventions
First Posted Date
2014-02-24
Last Posted Date
2014-02-24
Lead Sponsor
Liaoning University of Traditional Chinese Medicine
Target Recruit Count
451
Registration Number
NCT02069665
Locations
🇨🇳

Affiliated Children's Hospital of Capital University of Medical Sciences, Beijing, Beijing, China

🇨🇳

Affiliated Children's Hospital of Dalian Medical University, Dalian, Liaoning, China

🇨🇳

Affiliated Hospital of Liaoning University of TCM, Shenyang, Liaoning, China

and more 3 locations

Exploratory Efficacy Study of Guaifenesin in Upper Back Pain

Not Applicable
Completed
Conditions
Upper Back Pain
Interventions
Drug: Placebo
First Posted Date
2012-03-26
Last Posted Date
2014-06-03
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
78
Registration Number
NCT01562548
Locations
🇺🇸

Radiant Research, Inc. - TX, San Antonio, Texas, United States

🇺🇸

Med Investigations, Fair Oaks, California, United States

🇺🇸

J. Lewis Research, Salt Lake City, Utah, United States

and more 2 locations

Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections

Phase 2
Completed
Conditions
Acute Upper Respiratory Tract Infection
Interventions
First Posted Date
2012-02-22
Last Posted Date
2013-11-14
Lead Sponsor
Reckitt Benckiser LLC
Target Recruit Count
2810
Registration Number
NCT01537081
Locations
🇺🇸

Reckitt Benckiser Study Site, Spokane, Washington, United States

The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study

Phase 2
Completed
Conditions
Chronic Rhinitis
Interventions
Drug: Placebo
First Posted Date
2011-06-02
Last Posted Date
2020-04-24
Lead Sponsor
Virginia Commonwealth University
Target Recruit Count
30
Registration Number
NCT01364467
Locations
🇺🇸

Virginia Commonwealth University Children's Hospital of Richmond, Children's Pavilion & Nelson Clinic, Richmond, Virginia, United States

Comparison Between Oxomemazine, Guaifenesin and Potassium Iodate Versus Guaifenesin Monotherapy in Acute Cough Treatment

Phase 3
Completed
Conditions
Cough
Interventions
Drug: Syrup of oxomemazine, guaifenesin and potassium iodate
First Posted Date
2010-12-09
Last Posted Date
2019-04-17
Lead Sponsor
EMS
Target Recruit Count
260
Registration Number
NCT01257243
Locations
🇧🇷

Beneficência Nipo Brasileira de São Paulo - Hospital Nipo Brasileiro, São Paulo, Brazil

Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI

Phase 4
Completed
Conditions
Acute Upper Respiratory Track Infection
Interventions
Device: Placebo
First Posted Date
2010-09-15
Last Posted Date
2020-12-30
Lead Sponsor
Reckitt Benckiser Inc.
Target Recruit Count
1179
Registration Number
NCT01202279
Locations
🇺🇸

Coastal Connecticut Research, LLC, 342 Montauk Avenue, New London, Connecticut, United States

🇺🇸

Clinical Associates Research, 750 Main Street, Suite 310, Reisterstown, Maryland, United States

🇺🇸

Clinical Research Advantage, Inc., Mesa, Arizona, United States

and more 21 locations

Comparative Efficacy of the Suppository Versus Guaiacol Suppository Versus Guaifenesin Syrup in Pediatric Patients With Cough Due the Infectious Origin

Phase 3
Conditions
Cough
Interventions
Drug: Guaiacol, eucalyptol, menthol and camphor suppository
First Posted Date
2010-05-07
Last Posted Date
2011-01-28
Lead Sponsor
Azidus Brasil
Target Recruit Count
270
Registration Number
NCT01119534
Locations
🇧🇷

LAL Clínica Pesquisa e Desenvolvimento Ltda, Valinhos, SP, Brazil

Evaluating the Effect of Mucinex 1200mg on Mucociliary and Cough Clearance During an Acute Respiratory Infection

Phase 2
Completed
Conditions
Acute Respiratory Infection
Interventions
Drug: Placebo
First Posted Date
2010-05-03
Last Posted Date
2018-09-19
Lead Sponsor
Reckitt Benckiser LLC
Target Recruit Count
38
Registration Number
NCT01114581
Locations
🇺🇸

Center for Environmental Medicine, Asthma, and Lung Biology, Chapel Hill, North Carolina, United States

Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in Respiratory Infections

Phase 3
Conditions
Viral Infections of the Upper Respiratory Tract
Interventions
First Posted Date
2010-03-12
Last Posted Date
2010-03-12
Lead Sponsor
Mantecorp Industria Quimica e Farmaceutica Ltd.
Target Recruit Count
170
Registration Number
NCT01085721

Study of Count Coughs in Subjects With Acute Upper Respiratory Tract Infections

Not Applicable
Completed
Conditions
Infection
Interventions
Other: Buckwheat Honey
Drug: Placebo
First Posted Date
2010-02-04
Last Posted Date
2013-02-25
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
265
Registration Number
NCT01062256
Locations
🇺🇸

Pfizer Investigational Site, Lexington, Kentucky, United States

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