Guaifenesin
/ Guaifenesin, Flowtuss, Guaifenesin, Guaifenesin /, Hycofenix, Mucinex, Obredon, Xtrelus (guaifenesin) is a small molecule pharmaceutical. Guaifenesin was first approved as Mucinex on 2002-07-12. It is used to treat allergic rhinitis perennial, bronchitis, common cold, cough, and laryngitis amongst others in the USA.
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Commercial
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Guaifenesin, Mucinex
CombinationsGuaifenesin dextromethorphan, Guaifenesin pseudoephedrine, Mucinex, Mucinex d (discontinued: Flowtuss, Guaifenesin pseudoephedrine, Hycofenix, Obredon, Xtrelus)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Guaifenesin
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Hydrocodone bitartrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| FLOWTUSS | Chartwell Pharmaceuticals | N-022424 DISCN | 2015-05-14 | 1 products |
| XTRELUS | ECI Pharmaceuticals | N-208085 DISCN | 2018-04-25 | 1 products, RLD |
| OBREDON | Sovereign Pharmaceuticals | N-205474 DISCN | 2014-11-14 | 1 products, RLD |
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Guaifenesin
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Hydrocodone bitartrate
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Pseudoephedrine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| HYCOFENIX | Chartwell Pharmaceuticals | N-022279 DISCN | 2015-05-14 | 1 products, RLD |
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Dextromethorphan hydrobromide
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Guaifenesin
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 12 hour mucus relief | ANDA | 2024-10-11 |
| 24/7 life cold and flu daytime severe | C200263 | 2024-12-30 |
| 7 select | C200263 | 2024-07-29 |
| acetaflu cough and chest congestion | OTC monograph final | 2020-08-31 |
| acetaminophen 500mg, dextromethorphan hbr 10mg, guaifenesin 200mg, phenylephrine hcl 5mg | OTC monograph final | 2020-11-16 |
| acetaminophen dextromethorphan hbr guaifenesin phenylephrine hcl | OTC monograph final | 2020-11-09 |
| acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | C200263 | 2024-12-02 |
| acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl | C200263 | 2024-05-17 |
| acetaminophen, guaifenesin, phenylephrine hcl and dextromethorphan hbr | C200263 | 2024-10-29 |
| actidom dmx | C200263 | 2024-06-28 |
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Clinical Trials
738 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | 17 | 20 | 17 | 13 | 14 | 77 |
| Postoperative pain | D010149 | — | G89.18 | 5 | 6 | 12 | 34 | 12 | 68 |
| Healthy volunteers/patients | — | — | — | 50 | 1 | — | 2 | 6 | 59 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 11 | 12 | 13 | 9 | 17 | 59 |
| Infections | D007239 | EFO_0000544 | — | 3 | 6 | 9 | 14 | 9 | 39 |
| Chronic pain | D059350 | — | — | 3 | 3 | 8 | 8 | 5 | 26 |
| Cough | D003371 | — | R05 | 5 | 3 | 8 | 5 | 5 | 26 |
| Syndrome | D013577 | — | — | — | 6 | 6 | 3 | 8 | 23 |
| Neoplasms | D009369 | — | C80 | 8 | 4 | 4 | 2 | 4 | 21 |
| Acute pain | D059787 | — | R52 | 5 | 4 | 6 | 1 | 3 | 19 |
Show 158 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cocaine-related disorders | D019970 | — | F14 | 4 | 3 | 2 | — | — | 8 |
| Lymphoma | D008223 | — | C85.9 | 2 | 2 | 2 | — | 1 | 6 |
| Treatment-resistant depressive disorder | D061218 | — | — | 1 | 3 | 1 | — | — | 5 |
| Psychomotor agitation | D011595 | — | — | — | 2 | 2 | — | 1 | 5 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | 1 | 2 | — | 1 | 5 |
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | 1 | 3 | 1 | — | — | 4 |
| Sclerosis | D012598 | — | — | — | 3 | 1 | — | — | 4 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 2 | 1 | 1 | — | — | 4 |
| Peripheral nervous system diseases | D010523 | — | G64 | — | 4 | 1 | — | — | 4 |
| Rett syndrome | D015518 | Orphanet_778 | F84.2 | — | 2 | 1 | — | 1 | 4 |
Show 58 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperalgesia | D006930 | — | — | 1 | 2 | — | — | 2 | 5 |
| Diarrhea | D003967 | — | R19.7 | — | 1 | — | — | 3 | 4 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | 1 | 3 | — | — | — | 3 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | — | 2 | 3 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | 2 | 1 | — | — | — | 3 |
| Prostatic neoplasms | D011471 | — | C61 | 3 | 1 | — | — | — | 3 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | — | 2 | — | — | 1 | 3 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 2 | — | — | 1 | 3 |
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | — | 1 | — | — | 2 | 3 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 2 | 2 | — | — | — | 3 |
Show 102 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | — | — | 6 | — | — | — | 3 | 9 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 1 | — | — | — | 1 | 2 |
| Food-drug interactions | D018565 | — | — | 2 | — | — | — | — | 2 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 1 | — | — | — | 1 | 2 |
| Renal insufficiency | D051437 | — | N19 | 2 | — | — | — | — | 2 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 2 | — | — | — | — | 2 |
| Hepatic insufficiency | D048550 | — | — | 2 | — | — | — | — | 2 |
| Melanoma | D008545 | — | — | 1 | — | — | — | — | 1 |
| Hepacivirus | D016174 | — | — | 1 | — | — | — | — | 1 |
| Mitochondrial diseases | D028361 | EFO_0000591 | — | 1 | — | — | — | — | 1 |
Show 29 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Apnea | D001049 | — | R06.81 | — | — | — | — | 2 | 2 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | — | 2 | 2 |
| Emergence delirium | D000071257 | — | — | — | — | — | — | 2 | 2 |
| Whooping cough | D014917 | EFO_0000650 | A37 | — | — | — | — | 2 | 2 |
| Chronic cough | D000096822 | — | R05.3 | — | — | — | — | 2 | 2 |
| Periodontitis | D010518 | EFO_0000649 | K05.3 | — | — | — | — | 2 | 2 |
| Pregnancy rate | D018873 | — | — | — | — | — | — | 2 | 2 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 2 | 2 |
| Torsades de pointes | D016171 | EFO_0005307 | I47.21 | — | — | — | — | 1 | 1 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 1 | 1 |
Show 62 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Guaifenesin |
| INN | guaifenesin |
| Description | Guaifenesin is a member of methoxybenzenes. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COc1ccccc1OCC(O)CO |
Identifiers
| PDB | — |
| CAS-ID | 93-14-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL980 |
| ChEBI ID | — |
| PubChem CID | 3516 |
| DrugBank | DB00874 |
| UNII ID | 495W7451VQ (ChemIDplus, GSRS) |
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Guaifenesin
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Carbetapentane
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Phenylephrine
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Guaifenesin
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Chlophedianol
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Guaifenesin
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Chlorpheniramine
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Guaifenesin
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Codeine
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Guaifenesin
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Codeine
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Phenylpropanolamine
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Guaifenesin
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Dextromethorphan
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Guaifenesin
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Dextromethorphan
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Phenylephrine
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Guaifenesin
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Dyphylline
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Guaifenesin
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Ephedrine
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Guaifenesin
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Guaifenesin
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Hydrocodone
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Phenylephrine
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Hydrocodone
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Guaifenesin
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Oxtriphylline
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Guaifenesin
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Phenylephrine
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Guaifenesin
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Phenylpropanolamine
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Guaifenesin
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Pseudoephedrine
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Guaifenesin
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Theophylline
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Safety
Black-box Warning
Black-box warning for: Obredon
Adverse Events
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20,836 adverse events reported
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