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Drug ReportsGuaifenesin
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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Drug
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
stomatognathic diseasesD009057
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Guaifenesin, Mucinex
Combinations
Guaifenesin 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
+
Hydrocodone bitartrate
Tradename
Company
Number
Date
Products
FLOWTUSSChartwell PharmaceuticalsN-022424 DISCN2015-05-14
1 products
XTRELUSECI PharmaceuticalsN-208085 DISCN2018-04-25
1 products, RLD
OBREDONSovereign PharmaceuticalsN-205474 DISCN2014-11-14
1 products, RLD
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Guaifenesin
+
Hydrocodone bitartrate
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Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
HYCOFENIXChartwell PharmaceuticalsN-022279 DISCN2015-05-14
1 products, RLD
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Dextromethorphan hydrobromide
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Guaifenesin
Tradename
Company
Number
Date
Products
MUCINEX DMRB HealthN-021620 OTC2004-04-29
2 products, RLD
Guaifenesin
Tradename
Company
Number
Date
Products
MUCINEXRB HealthN-021282 OTC2002-07-12
2 products, RLD
Guaifenesin
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Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
MUCINEX DRB HealthN-021585 OTC2004-06-22
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
12 hour mucus reliefANDA2024-10-11
24/7 life cold and flu daytime severeC2002632024-12-30
7 selectC2002632025-07-18
acetaflu cough and chest congestionOTC monograph final2020-08-31
acetaminophen 500mg, dextromethorphan hbr 10mg, guaifenesin 200mg, phenylephrine hcl 5mgOTC monograph final2020-11-16
acetaminophen dextromethorphan hbr guaifenesin phenylephrine hclOTC monograph final2020-11-09
acetaminophen, dextromethorphan hbr ,guaifenesinC2002632025-09-22
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochlorideC2002632024-12-02
acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hclC2002632024-05-17
acetaminophen, guaifenesin, phenylephrine hcl and dextromethorphan hbrC2002632024-10-29
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Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
sinusitisEFO_0007486D012852J32
whooping coughEFO_0000650D014917A37
bronchitis—D001991J40
cough—D003371R05
pharyngitis—D010612R07.0
common coldEFO_0007214D003139J00
allergic rhinitis perennialEFO_1001417D012221J30.89
laryngitis—D007827—
asthmaEFO_0000270D001249J45
postoperative pain—D010149G89.18
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Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Guaifenesin / Hydrocodone Bitartrate, Obredon, Sovereign Pharms
95499072035-11-13DS, DPU-2023
98084312035-11-13DS, DPU-2023
101053242035-11-13DS, DPU-2023
ATC Codes
R: Respiratory system drugs
— R05: Cough and cold preparations
— R05C: Expectorants, excl. combinations with cough suppressants
— R05CA: Expectorants
— R05CA03: Guaifenesin
HCPCS
No data
Clinical
Clinical Trials
163 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Respiratory tract infectionsD012141—J06.9———1—1
Common coldD003139EFO_0007214J00———1—1
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGuaifenesin
INNguaifenesin
Description
Guaifenesin is a member of methoxybenzenes.
Classification
Small molecule
Drug classExpectorant
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COc1ccccc1OCC(O)CO
Identifiers
PDB—
CAS-ID93-14-1
RxCUI—
ChEMBL IDCHEMBL980
ChEBI ID—
PubChem CID3516
DrugBankDB00874
UNII ID495W7451VQ (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
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Estimated US medical usage
Guaifenesin
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Pentoxyverine
Total medical expenditures per year (USD, in millions)
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Guaifenesin
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Pentoxyverine
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Phenylephrine
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Guaifenesin
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Chlophedianol
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Guaifenesin
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Phenylephrine
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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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Guaifenesin
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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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,541 documents
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Safety
Black-box Warning
Black-box warning for: Obredon
Adverse Events
Top Adverse Reactions
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22,001 adverse events reported
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