Guaifenesin
ExpectorantsExpectorantDecreased Respiratory Secretion ViscosityIncreased Respiratory SecretionsUS-FDASourced from openFDA
GET
/api/v1/drug/guaifenesinIndications
Sourced from openFDA- Uses ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Dosage & administration
Sourced from openFDADirections ■ do not crush, chew, or break tablet ■ take with a full glass of water ■ this product can be administered without regard for timing of meals ■ adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours. ■ children under 12 years of age: do not use
Warnings & precautions
Sourced from openFDADo not use ■ for children under 12 years of age
Approval history
Sourced from openFDA- Jul 12, 2002NDANDA021282Rb Hlth
- Apr 29, 2004NDANDA021620Rb Hlth
- Jun 22, 2004NDANDA021585Rb Hlth
- Nov 23, 2011ANDAANDA078912Perrigo R And D
- Mar 17, 2017ANDAANDA206941Aurobindo Pharma
- Sep 6, 2017ANDAANDA209215Guardian Drug
- Dec 29, 2017ANDAANDA208369Dr Reddys
- Dec 22, 2025NDANDA217338Rb Hlth
FAERS reports
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
199,478 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
- 1Drug Ineffective21,98011%
- 2Fatigue18,5659.3%
- 3Nausea15,4407.7%
- 4Headache15,2357.6%
- 5Pain14,5237.3%
- 6Diarrhoea13,7056.9%
- 7Off Label Use13,3056.7%
- 8Dyspnoea12,5926.3%
- 9Arthralgia10,9825.5%
- 10Dizziness10,1385.1%
- 11Vomiting8,9654.5%
- 12Asthenia8,5074.3%
- 13Rash8,4424.2%
- 14Pyrexia8,3754.2%
- 15Cough7,8173.9%
Literature
Recent PubMed references pinned to Guaifenesin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Comparative greenness assessment for the simultaneous estimation of diclofenac and methocarbamol in their tablets applying synchronous fluorimetry.Scientific reports · 2026 · Attia M, Hadad GM, Salam RAA, et al.PMID 41866376DOI 10.1038/s41598-026-41615-y
- Evolving Analytical Methods for the Quantification of Methocarbamol: A Critical Review.Biomedical chromatography : BMC · 2026 · Barzani HAH, Omer RA, Abdulrahman NB, et al.PMID 41841242DOI 10.1002/bmc.70419
- Green analytical method for determination of oxeladin citrate using advanced electrochemical modified sensors in pure form, pharmaceuticals, human serum and binary mixtures with guaifenesin.Scientific reports · 2026 · Hammad SF, Hendawy HA, Habib HM, et al.PMID 41545455DOI 10.1038/s41598-025-32960-5
- Guaifenesin and dextromethorphan for management of cough and mucus-related cold symptoms in adults: a narrative literature review.Postgraduate medicine · 2025 · Bateman MT Jr, Brunton S, Wright WL, et al.PMID 41423743DOI 10.1080/00325481.2025.2603034
- Intravenous magnesium and methocarbamol for acute pain crises in refractory trigeminal neuralgia: A retrospective analysis.Headache · 2026 · Ong B, Lomachinsky-Torres V, Mandava N, et al.PMID 41200814DOI 10.1111/head.15097
- Chemometrics-Assisted Spectrophotometric Methods for Determination of Methocarbamol and Paracetamol Along With Two Related Impurities: An Environmental Sustainability Assessment.Archiv der Pharmazie · 2025 · Kelani KM, Essam HM, Mohamed AR, et al.PMID 41074255DOI 10.1002/ardp.70114
- Disposable Face Masks for Noninvasive Drug Detection: A Proof-of-Concept Study with Cough Syrup Constituents.Analytical chemistry · 2025 · Tse HT, Yu JZ, Cai Z, et al.PMID 40323120DOI 10.1021/acs.analchem.5c01129
- Ultrasensitive First Derivative Synchronous Spectrofluorimetric Approach for the Concurrent Quantification of COVID-19-2024 Treatment Combination Dextromethorphan and Guaifenesin in Different Matrices: Compliance With Greenness and Practicality Metrics.Luminescence : the journal of biological and chemical luminescence · 2025 · Alrashidi AA, Salim MM, Alharthi S, et al.PMID 40194837DOI 10.1002/bio.70165
Clinical trials
The 10 most recently updated of 170 ClinicalTrials.gov registrations naming Guaifenesin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- A 52-Week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream in Adult Participants With Lichen SclerosusRecruiting · Phase 3 · Interventional · 652 enrolled · LEO PharmaNCT07335588updated 2026-06-09
- Nonopioid Pain Control Regimen After Arthroscopic Hip ProceduresCompleted · Phase 4 · Interventional · 86 enrolled · Mayo ClinicNCT05076110updated 2026-06-03
- Effect of Nicotinamide Riboside on Ketosis, Fat Oxidation & Metabolic RateRecruiting · Interventional · 100 enrolled · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NCT06044935updated 2026-05-22
- Expanded Access Program for Tiratricol in Patients With Monocarboxylate Transporter 8 DeficiencyAvailable · Expanded access · Rare Thyroid Therapeutics International ABNCT05911399updated 2026-05-05
- Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy ProcedureActive not recruiting · Interventional · 126 enrolled · Northwestern UniversityNCT05100017updated 2026-04-30
- The Efficacy of the 7 Days Tailored Therapy as the 1st Eradication of H. Pylori InfectionRecruiting · Interventional · 600 enrolled · Seoul National University Bundang HospitalNCT02373280updated 2026-04-24
- Study of NMDA Antagonists and Neuropathic PainCompleted · Phase 2 · Interventional · 7 enrolled · University Hospital, Clermont-FerrandNCT01602185updated 2026-04-21
- Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial FibrillationNot yet recruiting · Interventional · 224 enrolled · Beijing Anzhen HospitalNCT07541339updated 2026-04-21
- Efficacies of Susceptibility-guided vs Empiric Therapy for Rescue Treatment of Helicobacter Pylori InfectionRecruiting · Phase 4 · Interventional · 450 enrolled · National Taiwan University HospitalNCT05332444updated 2026-04-15
- Withdrawal of Tiratricol Treatment in Males With Monocarboxylate Transporter 8 Deficiency (MCT8 Deficiency)Completed · Phase 3 · Interventional · 20 enrolled · Rare Thyroid Therapeutics International ABNCT05579327updated 2026-04-08
Frequently asked questions
- What is Guaifenesin used for?
- According to FDA labeling, Guaifenesin carries indications including: Uses ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Guaifenesin?
- Guaifenesin is classified as Expectorants, Expectorant, Decreased Respiratory Secretion Viscosity, Increased Respiratory Secretions.
- What are the brand names for Guaifenesin?
- Guaifenesin is marketed under brand names including Allfen CX, Allfen Jr, Ambifed CD, Ambifed-G CD, Bidex, Biotussin, Bronkaid, Brontex.
Note. Data for
guaifenesin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.