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Last update 26 Jul 2026

Guaifenesin

Last update 26 Jul 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryGuaifenesin, approved for medical use in Japan in 1949, is an expectorant medication found in numerous over-the-counter products. Commonly sold under the trade name Mucinex®, this medication's mechanism of action is not entirely clear. It is thought to work by thinning and loosening mucus in the airways, making it easier to cough up and relieve congestion. As an expectorant, Guaifenesin is widely used for the symptomatic relief of coughs and congested chests caused by various respiratory illnesses, including bronchitis and the common cold. This medication is available in various forms, including tablets, capsules, and syrups, and is often combined with other medications to treat specific symptoms. Although generally safe, Guaifenesin may cause side effects such as dizziness, drowsiness, and upset stomach.

Drug Type

Small molecule drug

Synonyms

Glyceryl guaiacolate, Guaifenesin (JP17/USP/INN), Guaifenesine

+ [11]

Target-

Action-

Mechanism-

Therapeutic Areas

Respiratory Diseases

Active Indication

CoughSputum excretion difficultyRespiratory Diseases

Inactive Indication

Acute lower respiratory tract infectionAcute respiratory infectionsAcute upper respiratory infection+ [3]

Originator Organization

Kyoto Pharmaceutical Industries Ltd.

Active Organization

Reckitt Benckiser Group Plc

Kyoto Pharmaceutical Industries Ltd.

Reckitt Benckiser LLC

+ [1]

Inactive Organization

Reckitt Benckiser, Inc.Anhui Pharmaceutical Technology Industrial Company

Hefei Cosource Pharmaceuticals, Inc.

License Organization-

Drug Highest PhaseApproved

First Approval Date

Japan (20 Mar 1949),

CoughSputum excretion difficulty

Regulation-

Structure/Sequence

Molecular FormulaC10H14O4

InChIKeyHSRJKNPTNIJEKV-UHFFFAOYSA-N

CAS Registry93-14-1

Clinical Trials associated with Guaifenesin

NCT06716645

/ CompletedPhase 4

A Real-World Evidence Study Evaluating Quality of Life Parameters Following Treatment With Robitussin

The purpose of this Real-World Evidence study is to generate real world data from participants with cough associated with the common cold, evaluating the effects in two arms with commercially available cough syrups on health-related quality of life (QoL). Arm 1 includes one cough syrup (which can be used day or night) and Arm 2 includes the daytime cough syrup and a nighttime cough syrup.

Start Date04 Dec 2024

Sponsor / Collaborator

Haleon Plc

CTR20232759

/ CompletedNot Applicable

愈创木酚甘油醚双层缓释片人体生物等效性研究

[Translation] Study on the bioequivalence of guaifenesin bilayer sustained-release tablets in healthy volunteers

采用单中心、随机、开放、双周期交叉、单次口服试验设计比较空腹和餐后给药条件下，北京柏雅联合药物研究所有限公司提供的愈创木酚甘油醚双层缓释片（600 mg）与RB HEALTH US LLC生产的愈创木酚甘油醚双层缓释片（600 mg，商品名：Mucinex®）在中国健康人群吸收程度和吸收速度的差异，并评价北京柏雅联合药物研究所有限公司提供的愈创木酚甘油醚双层缓释片的安全性。

[Translation]

A single-center, randomized, open, two-period crossover, single oral trial design was used to compare the differences in absorption extent and rate of guaifenesin bilayer sustained-release tablets (600 mg) provided by Beijing Boya United Pharmaceutical Research Institute Co., Ltd. and guaifenesin bilayer sustained-release tablets (600 mg, trade name: Mucinex®) produced by RB HEALTH US LLC in healthy Chinese people under fasting and postprandial administration conditions, and to evaluate the safety of guaifenesin bilayer sustained-release tablets provided by Beijing Boya United Pharmaceutical Research Institute Co., Ltd.

Start Date04 Oct 2023

Sponsor / Collaborator

Beijing Baiya United Medicine Research Institute Co.,Ltd.

NCT05843669

/ CompletedPhase 4

An Open-label, Multicenter, Single-group Study to Evaluate the Effects of Long-term Use of Mucinex® in Patients With Stable Chronic Bronchitis.

This is an open-label, multicenter, single-group study designed to determine the effectiveness of Mucinex® when used by patients to treat SCB over a 12-week period, following a 2-week run-in period of no treatment (to establish a baseline).

Start Date17 Jul 2023

Sponsor / Collaborator

American Health Research, LLC

[+1]

100 Clinical Results associated with Guaifenesin

100 Translational Medicine associated with Guaifenesin

100 Patents (Medical) associated with Guaifenesin

902

Literatures (Medical) associated with Guaifenesin

03 Jun 2026·CLINICAL TOXICOLOGY

Intentional pediatric nonprescription cold/cough and analgesic/antipyretic exposure trends amid the COVID-19 pandemic

Article

Author: Chang, Dorothy ; Pinnow, Ellen ; Karami, Sara ; Asonye, Ajoa ; McCulley, Lynda ; Ventura, Christian Angelo I. ; Zhou, Esther H. ; Ibrahim, Ibrahim ; Dal Pan, Gerald J. ; Meyer, Tamra

INTRODUCTION:

The objective of this study is to examine US Poison Center intentional pediatric nonprescription analgesics/antipyretic and cold/cough exposure trends involving abuse/misuse and suspected suicide amid the COVID-19 pandemic.

METHODS:

Using descriptive and interrupted time-series analyses, we assessed monthly pediatric (6-17 years) exposure case rates involving nonprescription analgesic/antipyretic drugs containing paracetamol (acetaminophen), ibuprofen, acetylsalicylic acid, and naproxen, and cold/cough drugs containing dextromethorphan, guaifenesin, pseudoephedrine, and phenylephrine, before (1/1/2015-2/29/2020) and during (4/1/2020-4/30/2023) the COVID-19 pandemic. Statins served as a control.

RESULTS:

Nearly half of pediatric intentional cough/cold (40-56%) and analgesic/antipyretic (51-62%) cases involved a single substance, unlike the control (22%). Most cases entailed intentional-suspected suicide exposures (cold/cough 55-78%; analgesic/antipyretic 89-92%; control 96%) followed by intentional-abuse/misuse (cold/cough 17-40%; analgesic/antipyretic 6-8%; control 3%). Cases commonly involved adolescents, 13-17 years (cold/cough 88-93%; analgesic/antipyretic 90-92%; control 88%) and females (cold/cough 56-71%; analgesic/antipyretic 84-85%; control 82%). Paracetamol intentional-abuse/misuse and dextromethorphan suspected suicide case rates declined immediately following the pandemic's onset (March 2020), among adolescents. Case rates for guaifenesin, paracetamol, and ibuprofen intentional-suspected suicides exceeded pre-pandemic levels and exhibited statistically significant increased trend changes for adolescents (0.016, 0.246, and 0.116 cases per million population per month, respectively); and for guaifenesin for female (0.03 cases per million population). Male and female intentional-abuse/misuse case rates trends for some study drugs also increased; primarily for adolescents.

CONCLUSION:

Some analgesic/antipyretic and cold/cough intentional-suspected suicide case rates notably increased during the pandemic for adolescents, particularly females. This surge aligns with periods of increased psychological stress, suicidal ideation/attempts, and certain nonprescription drug exposures potentially attributed to the COVID-19 pandemic.

17 Nov 2025·POSTGRADUATE MEDICINE

Guaifenesin and dextromethorphan for management of cough and mucus-related cold symptoms in adults: a narrative literature review

Review

Author: Bateman, M. Thomas ; Wright, Wendy L. ; Brunton, Stephen

OBJECTIVES:

For many decades, guaifenesin and dextromethorphan have been two of the most well-established and commonly used nonprescription medications to manage cough and cold symptoms. A single source that summarizes the clinical data supporting the use of guaifenesin and dextromethorphan as self-care treatment options in cough and cold could assist healthcare professionals (HCPs) in making informed recommendations to patients. The objective of this narrative review is to discuss the benefits of guaifenesin and dextromethorphan for the management of cough and mucus-related cold symptoms in adults by examining published data on the effectiveness and safety of the products containing these ingredients.

METHODS:

Literature searches were performed on PubMed, Embase, and MEDLINE to identify randomized, controlled studies comparing guaifenesin or dextromethorphan treatment with placebo control in adults with cough and cold (mucus) symptoms. Of 36 guaifenesin and 53 dextromethorphan clinical studies initially identified by the literature search, 13 guaifenesin and 19 dextromethorphan publications met the predefined inclusion criteria. Additional studies were identified during manuscript development by reviewing the citations of included articles, for a total of 17 guaifenesin and 21 dextromethorphan publications.

RESULTS:

Data from studies of guaifenesin and dextromethorphan either used alone or combined with other active ingredients showed statistically significant improvements compared with placebo control in sputum looseness/adhesiveness and reductions in cough frequency/severity, respectively. A small number of studies did not show significant improvements with study drug compared with placebo control. Conflicting data may originate from differences in study design, patient enrollment, and a relatively high placebo control effect across studies.

CONCLUSION:

The data reviewed in this article support the importance of guaifenesin and dextromethorphan in the armamentarium of effective nonprescription treatment options for cough and mucus-related cold symptoms.

01 Oct 2025·ARCHIV DER PHARMAZIE

Chemometrics‐Assisted Spectrophotometric Methods for Determination of Methocarbamol and Paracetamol Along With Two Related Impurities: An Environmental Sustainability Assessment

Article

Author: Yasmine F. Bassuoni ; Khadiga M. Kelani ; Hebatallah M. Essam ; Ahmed R. Mohamed

ABSTRACT:

Two multivariate calibration models were created for the concurrent estimation of methocarbamol and paracetamol in their co‐formulated pharmaceutical dosage form. These methods also enabled the detection of their impurities, p ‐aminophenol and guaifenesin. The calibration paradigms, based on principal component regression (PCR) and partial least squares (PLS), were employed to assess the drugs and their impurities. The methods demonstrated accurate simultaneous determination of methocarbamol, paracetamol, p ‐aminophenol, and guaifenesin within the concentration ranges of 20.00–80.00 µg mL −1 for methocarbamol, 20.00–60.00 µg mL −1 for paracetamol, 0.06–4.00 µg mL −1 for p‐ aminophenol, and 0.08–10.00 µg mL −1 for guaifenesin. The techniques were evaluated in accordance with ICH directions, and the outcomes confirmed the reliability and validity of the developed methods. The suggested approaches were successfully applied to analyze methocarbamol and paracetamol in their combined tablets and to quantify their related impurities. Furthermore, the environmental impact of these techniques was evaluated using a variety of metrics, assessing their greenness and whiteness alongside their practical effectiveness (blueness), with the results highlighting their superior environmental performance. Additionally, the suggested techniques' sustainability was appraised using the recently introduced NQS index, yielding a score of 67.70%, demonstrating strong alignment with sustainable analytical practices.

News (Medical) associated with Guaifenesin

28 Nov 2025

·www.aftpharm.com

New York Times: Some cold medicines may have higher than expected levels of a decongestant

Some widely used over-the-counter cold and flu medicines may be exposing patients to unexpectedly high amounts of one ingredient, revealing a lapse in regulations and perhaps raising safety concerns, a company that develops such drugs reported on Wednesday. The company, AFT Pharmaceuticals of New Zealand, said that when the nasal decongestant phenylephrine, or PE, was combined with the pain reliever acetaminophen, levels of PE in the blood were two to four times as high as when the same dose of PE was taken alone. “Effectively, accidentally you are getting a higher dose here,” said Hartley C. Atkinson, chief executive for AFT. He and colleagues reported their finding in a brief correspondence published on Wednesday online in The New England Journal of Medicine website. The letter said the combination increased exposure to PE “beyond levels that were previously deemed to be safe and effective.” Drugs that combine PE and acetaminophen, which is the active ingredient in Tylenol, are common and include certain versions of Robitussin, Theraflu, Mucinex, DayQuil, Tylenol Cold and Flu and other brands. AFT sells a combination product in some markets outside of the United States. The potential adverse side effects from a high dose of PE could include higher blood pressure, elevated heart rate and nervousness. The Food and Drug Administration said it was aware of the finding but suggested it was not a safety concern. It said in a statement that PE was generally recognized as safe, including in combination with acetaminophen. The Consumer Healthcare Products Association, which is based in Washington and represents over-the-counter drug manufacturers, also dismissed any concerns, saying PE had been used safely for decades. Ron Eccles, director of the common cold center at Cardiff University in Britain, who was not involved in the study, said that while he did not think there were serious risks, “Regulatory authorities need to address this issue quickly to reassure the public that these freely available medicines are safe.” Still, the F.D.A. declined several years ago to increase the permitted dose of PE to 25 milligrams from 10 milligrams. Dr. Atkinson of ATF said that 10 milligrams of PE taken in combination with acetaminophen leads to blood levels similar to what would come from taking 25 milligrams of PE by itself. The Consumer Healthcare Products Association, in a 2007 document arguing against the dose increase, said that studies had found that the 25- milligram dose was more frequently associated with increased pulse rate and nervousness than the lower dose. An F.D.A. review concluded, however, that past studies “suggest only negligible effects” at either dose. The use of PE as a nasal decongestant increased markedly several years ago after access to another decongestant, pseudoephedrine, was restricted because it was being used to make methamphetamines. Some experts said the finding of the unexpected interaction of acetaminophen and PE showed that over-the-counter drugs need to be tested more thoroughly before being allowed on the market. “There’s a major public policy issue with respect to how over-the- counter products are regulated,” said Dr. Joshua Sharfstein, secretary of health and mental hygiene in Maryland and a former principal deputy commissioner of the F.D.A. Dr. Sharfstein was involved in 2007 in an effort to prohibit the use of certain cold medicines by infants and young children. Dr. Atkinson said his company discovered this effect in the course of developing a combination of PE, acetaminophen and ibuprofen. It found that levels of PE in the blood of people who took this combination were much higher than expected. Further testing showed that the effect was because of the acetaminophen, not the ibuprofen. He said it appeared that acetaminophen interfered with the breakdown of PE, allowing higher levels to build up in the blood. Still, the data for blood levels of PE shown in The New England Journal of Medicine website was for the triple combination. In its statement, the F.D.A. suggested the finding was irrelevant because the triple combination was not permitted to be sold in the United States. AFT is developing a combination product with half the usual dose of PE. It would benefit commercially if it could establish that the existing dose used in rival products raises safety issues. There is also controversy over whether PE is even effective. Leslie Hendeles, a professor of pharmacy and pediatrics at the University of Florida, said PE had only a minor effect at the dose used. Rather than raising safety concerns, he said, the finding that the effective dose of PE is increased in the combination medicines “would actually render what is an ineffective compound effective.” Source: New York Times, Andrew Pollack, 19 March 2014

Clinical Result

20 Oct 2025

·www.prnewswire.com

Long-Term Study of Extended-Release Guaifenesin Shows Symptom Relief in Stable Chronic Bronchitis Patients

Findings presented at CHEST from the 12-week real world evidence GASP Study underscore clinical relevance, patient satisfaction, and quality-of-life gains, supporting adjunctive use of Mucinex® (extended-release guaifenesin) in chronic respiratory care. PARSIPPANY, N.J., Oct. 20, 2025 /PRNewswire/ -- Reckitt, the maker of Mucinex®, the #1 physician-trusted cough and cold brand*, announced new outcomes from the Guaifenesin Assessment of Satisfaction for Patients (GASP) Study, the first long-term evaluation of extended-release (ER) guaifenesin (Mucinex) at 1200 mg twice daily (2,400 mg) over 12 weeks in patients with stable chronic bronchitis (SCB). The findings demonstrate clinically meaningful reductions in cough and sputum severity, improved quality of life impact, and high patient satisfaction, offering clinicians new real-world evidence to inform adjunctive management strategies for chronic mucus-related respiratory disease. Historically, guaifenesin data in chronic respiratory care has been limited to short-term (≤14-day) use. The GASP Study, an investigator-initiated study (IIS) conducted under the direction of Dr. Selwyn Spangenthal and funded via a grant by Reckitt, addresses this critical evidence gap, showing sustained symptom improvement using the Cough and Sputum Assessment Questionnaire (CASA-Q), a validated patient-reported outcome measure (PROM). Improvements exceeded the minimal clinically important difference (MCID) across all domains, signaling measurable benefits in health-related quality of life (HRQoL). Mucinex 12-Hour is indicated to thin and loosen mucus in patients with stable chronic bronchitis, helping to make coughs more productive and ease chest congestion. "For patients living with persistent cough and sputum burden, especially those with chronic bronchitis, long-term symptomatic relief is a significant unmet need," said Dr. Selwyn Spangenthal, principal investigator, and respiratory clinician. "This data reinforces the potential role of guaifenesin ER as a supportive therapy that is both effective and well-tolerated over a daily ongoing treatment period." The 12-week, GASP Clinical Study was conducted as an open-label, single-cohort investigation evaluating daily use of guaifenesin ER (2,400 mg) in adults aged 40 years or older with stable chronic bronchitis. Patients continued their standard maintenance therapies while symptom severity and quality of life impact were measured weekly using the validated CASA-Q patient-reported outcome tool. This pragmatic design allowed researchers to assess long-term effectiveness, adherence, tolerability, and quality-of-life impact in a real-world setting. Key findings include: Sustained Symptom Reduction: Daily administration of 2400 mg guaifenesin ER produced continuous reductions in cough and sputum symptoms over 12 weeks. Clinically Meaningful Outcomes: CASA-Q scores consistently surpassed the MCID threshold 3 weeks after starting treatment across all domains, showing significant impact on patient function and daily quality of life. High Patient Adherence and Satisfaction: > 90% of Participants reported treatment compliance weekly, supporting feasibility and commitment to long-term adjunctive use in SCB management. Strong Symptom Correlation: Analysis showed a near-perfect correlation (r=0.98) between cough and sputum domains, reinforcing mucus management as a driver of overall symptom relief. These findings provide clinicians with: An evidence based daily long-term dosing strategy for chronic symptom management and foundation for integrating guaifenesin ER as an adjunctive therapy A PRO-based framework (CASA-Q) to track treatment benefits and functional improvement Data from the GASP Study was shared at the CHEST 2025: Advancing Excellence and Innovation conference, hosted in Chicago on October 20th, 2025. The study results have also been accepted or presented at other major scientific forums including the London Cough Conference , ATS and American Cough Conference with further presentations scheduled at ISOQOL and GOLD International COPD conference. Abstract publications is pending in leading respiratory journals. "At Reckitt, we believe that meaningful innovation in respiratory health begins with a deep understanding of patient needs and real-world outcomes," said Tim Shea, Senior Medical Scientist, Respiratory Research and Development. "The GASP Study represents a significant step forward in addressing a long-standing evidence gap in chronic bronchitis management—specifically, the long-term use of extended-release guaifenesin (Mucinex®) as an adjunctive therapy." For more information about the GASP study, visit Research and Clinical Studies Dr. Selwyn Spangenthal is Board Certified in Internal Medicine and Pulmonology and is a Certified Physician Investigator through the Association of Clinical Research Professionals (ACRP). He studied medicine at the University of Cape Town, South Africa and attained MRCP (Member of the Royal College of Physicians) in London, United Kingdom. His Pulmonary fellowship was done at Tufts New England Medical Center, 1980-1982. Dr. Spangenthal has been the Principal Investigator on numerous Clinical Research studies since 1987. A great number of these drugs are now FDA approved and readily available for patient care worldwide. Dr. Spangenthal is the leading physician at American Health Research. About Mucinex For more than 20 years, Mucinex has helped consumers breathe easier with trusted relief from cough, chest congestion, and mucus. As the number one selling cough and chest congestion brand, Mucinex offers a range of 12-hour products that work to thin and loosen excess mucus, relieve chest congestion, and control coughing. The Mucinex 12-Hour line, including Mucinex DM for cough and chest congestion and Mucinex SE for chest congestion, provides powerful, long lasting relief day or night. Mucinex has provided consumers with world-class mucus and congestion relief, and it is #1 in more categories than you can imagine: The #1 most trusted brand among physicians for cough and cold symptoms* The #1 most trusted brand among respiratory specialists for cough and cold symptoms** The #1 most trusted brand among physicians for their own family's cough & cold symptoms*** For more information, visit Mucinex.com. About Reckitt We make the products people trust to care for the ones they love. We are home to some of the world's best-loved consumer health and hygiene brands, including Dettol, Durex, Finish, Gaviscon, Harpic, Lysol, Mucinex, Nurofen, Strepsils, Vanish and Veet. Consumers are at the heart of everything we do. By creating innovative, science-backed solutions, we support people every day to live healthier lives. Reckitt**** exists to protect, heal, and nurture in the pursuit of a cleaner, healthier world. This commitment goes beyond the products we make. Through our actions, we expand access to healthcare, education, and economic opportunities. We support the planet by reducing waste, conserving resources, and driving sustainable innovation. We believe good health starts at home. With every action we take, we strive to make our consumers' lives easier, cleaner and healthier, to strengthen communities and to create a more sustainable future. Find out more or get in touch with us at . * IQVIA, ProVoice Survey, fielded to 3,930 physicians, September 1-December 31, 2024 ** IQVIA, ProVoice Survey, fielded to 570 respiratory specialists, September 1-December 31, 2024 *** IQVIA, ProVoice Survey, fielded to 3,930 respiratory specialists, September 1-December 31, 2024 ****Reckitt is the trading name of the Reckitt group of companies SOURCE MUCINEX WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical Result

16 Oct 2025

·pharma.economictimes.indiatimes.com

Under the scanner, yet generic cough syrups hit shelves

Mumbai: Tamil Nadu-based Sresan Pharmaceuticals ' cough syrup brand Coldrif that allegedly caused the deaths of more than 20 children in Madhya Pradesh is among thousands of generic cough syrup brands currently available in the domestic market, thriving below the regulatory radar. In less than a fortnight, cough syrups from at least three companies Sresan, Rednex and Shape Pharma have been found to contain diethylene glycol, an industrial solvent known to be poisonous and prohibited for use in producing medicines. However, this could just be the tip of the iceberg. Difficult to Capture Data PharmaTrac , a leading prescription audit firm, has coverage on sales of about 1,150 cough syrup brands in India, but sector experts believe the market is extremely fragmented and the actual count could be twice as much. Cough and cold syrups, popular fever drugs, or pain and inflammation medicines are among the most aggressively marketed to doctors by small and regional pharma companies . "Incentives by smaller and regional companies sway the decisions of the doctors (to prescribe) more than the reputation of brands," said a senior area manager in a Mumbai-based pharma company. "In addition, in small towns, less than 100 kms from Mumbai, a shop chemist can recommend a brand of a drug to the customer." Retail-level data and trends for such small companies is not captured by audit firms like PharmaTrac as they are either insignificant in size or operate in regions beyond these firms' coverage area. Sresan's Coldrif does not figure in the sales audits of PharmaTrac. Though data for small pharma units is unavailable, sales of cough and cold syrups in India have risen 30% to ₹3,423 crore from ₹2,627 crore over the last five years outpacing the average pharma industry growth rate of 8-10%, showed data from PharmaTrac. While unethical trade practices are a major factor, sales of cough and cold syrups are also being fuelled by rapid urbanisation, air pollution, and frequent weather changes triggering dust allergies and respiratory distress across age groups though it is more pronounced in children. Besides, irrational fixed dose combinations are being pumped into the market by small companies despite a sweeping crackdown a few years ago, and a ban on hundreds of cough syrup brands. Regional Disparity Inefficient oversight of state Food and Drug Administrators (FDAs) have helped unscrupulous companies to swamp the market with irrational combinations. In 2023, out of 14 irrational drugs banned for sale by the central drug administration, 13 were combinations for the treatment of cough, cold, asthma, and respiratory infections. These included amoxycillin + bromhexine + dextromethorphan, chlorpheniramine maleate + codeine and dextromethorphan + chlorpheniramine + guaifenesin + ammonium chloride. Leading drugmakers are capitalising on the growth potential. Pfizer 's Corex DX is at the top of the heap with sales of ₹266 crore (moving annual total September 2025), followed by AsthaKind DX from Mankind Pharma at ₹129 crore. However, the competition intensifies from the third slot with Maxtra of Emcure Pharma garnering ₹128 crore and Abbott's Tossex at ₹114 crore. Interestingly, as per PharmaTrac data, at least 600 cough syrup brands have not registered any sales during the year. The sales of cough syrup brands also highlighted regional disparity. PharmaTrac data showed Bihar and Jharkhand are the biggest cough syrup consuming states with sales of ₹315 crore. By Vikas Dandekar ,

100 Deals associated with Guaifenesin

External Link

KEGG	Wiki	ATC	Drug Bank
D00337	Guaifenesin	R05CA03	DB00874

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Cough	Japan	Kyoto Pharmaceutical Industries Ltd.	20 Mar 1949
Sputum excretion difficulty	Japan	Kyoto Pharmaceutical Industries Ltd.	20 Mar 1949

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acute upper respiratory infection	Phase 3	United States	Reckitt Benckiser LLC	01 Sep 2011
Acute upper respiratory tract inflammation	Phase 3	United States	Reckitt Benckiser LLC	01 Sep 2011
Acute respiratory infections	Phase 2	United States	Reckitt Benckiser LLC	01 Apr 2010
Acute lower respiratory tract infection	Phase 2	United States	Reckitt Benckiser, Inc.	01 Dec 2009
Common Cold	Phase 2	United States	Reckitt Benckiser, Inc.	01 Dec 2009
Productive Cough	Phase 1	-	Reckitt Benckiser, Inc.	30 Jun 2009
Respiratory Diseases	Preclinical	United States	Lovelace Respiratory Research Institute	01 Sep 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06716645 (CTgov)	Phase 4	Cough \| Common Cold	244	Robitussin Maximum Strength Cough+Chest Congestion DM (Robitussin Cough Syrup (Daytime))	paxllujfdx(wkvdhfzubt) = pjzgztjmcj awxrkegfyi (ilnepoaear, tzofrbtltj - wiptgqpqdx) View more	-	20 Feb 2026
				Robitussin Maximum Strength Nighttime Cough DM+Chest Congestion DM (Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime))	paxllujfdx(wkvdhfzubt) = oqsaqyvchb awxrkegfyi (ilnepoaear, mfhnuxjfsl - wepsxvzknp) View more
NCT01364467 (CTgov)	Phase 2	Chronic rhinitis	30	Placebo (Placebo)	eopjndgvho(modiucailm) = qxeryyoyfr xhpkozzosk (vvdeggzpvr, 0.59) View more	-	24 Apr 2020
				Guaifenesin (Guaifenesin)	eopjndgvho(modiucailm) = pnuuobuink xhpkozzosk (vvdeggzpvr, 1.04) View more
NCT02859246 (CTgov)	Not Applicable	Keratitis	15	Mucinex®	iochgrigzb(ikivtbgxtd) = suvcsekids zboulzkbox (djpoysuhec, 2.9) View more	-	19 Feb 2020
NCT03642873 (CTgov)	Phase 1	-	24	Humibid® (Treatment A)	ioyqanpzqu = ojtvprsbtf jqdbdpicvb (kfvdyfnryv, fcqvfzqhyt - ggmiliwakc) View more	-	20 Jun 2019
				Hydrocodone Bitartrate (Treatment B)	ioyqanpzqu = xjytfriudt jqdbdpicvb (kfvdyfnryv, nihrtepnqp - otbftbvvst) View more
NCT03644095 (CTgov)	Phase 1	-	30	guaifenesin ER (Test (Treatment A))	qsfyjncogr(tgfdjphitg) = kxgutugvvw qgjagvdlea (dndeyvlbrg, 469) View more	-	19 Jun 2019
				Guaifenesin (Reference (Treatment B))	qsfyjncogr(tgfdjphitg) = htycfkgjcy qgjagvdlea (dndeyvlbrg, 575) View more
NCT03633448 (CTgov)	Phase 1	-	24	Guaifenesin (Treatment A (Adolescents))	cruwbbcmyp(acfvloxxyd) = dpfgfulnhn ezwiibefog (zmejwdsvvl, 929) View more	-	17 Jun 2019
				Guaifenesin (Treatment A (Adults))	cruwbbcmyp(acfvloxxyd) = lmhyflnodl ezwiibefog (zmejwdsvvl, 742) View more
NCT03642262 (CTgov)	Phase 1	-	30	Mucinex® (Treatment A: Mucinex® ER 600 mg)	fxmemlwnuo(xzlwvdadna) = ausbgiiumi rbehqciuzy (wheyfmunnp, qvnkfhguoc - qnekvskdov) View more	-	17 Jun 2019
				Mucinex® (Treatment B: Guaifenesin 200 mg)	fxmemlwnuo(xzlwvdadna) = tutzjfaqec rbehqciuzy (wheyfmunnp, jqvdxfsvpf - hrcfqszcyr) View more
NCT03725085 (CTgov)	Phase 4	Cough \| Pulmonary Congestion	552	Mucinex	jsqrprqxth = hunyqvillt xjaurxggji (pooofjhnum, praduhbblv - fqjlxrfojs) View more	-	19 Mar 2019
NCT03633487 (CTgov)	Phase 1	-	24	Mucinex®	fpgntthxbo(msgdszrwls) = hgnlwdsxwk ybegveqoac (vrlxlautsy, 769.95) View more	-	28 Feb 2019
NCT03644108 (CTgov)	Phase 1	-	30	Mucinex	xsnnqqjhdo(tdrtezsihi) = qqfwqxylqy gpbeytzfqt (hzmaynblnf, 45.1) View more	-	28 Feb 2019

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