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Guaifenesin
Flowtuss, 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
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
Mucinex (generic drugs available since 2011-11-23)
Combinations
Mucinex, Mucinex d (generic drugs available since 2011-11-23, discontinued: Flowtuss, 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)
Dextromethorphan hydrobromide
+
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
+
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
Hide discontinued
Guaifenesin
+
Hydrocodone bitartrate
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
HYCOFENIXChartwell PharmaceuticalsN-022279 DISCN2015-05-14
1 products, RLD
Hide discontinued
Guaifenesin
+
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
mucinex-sinus max severe congestion and pain clear and cool and mucinex nightshift sinus clear and coolOTC monograph final2023-04-20
mucus relief severe congestion and sinusOTC monograph final2023-05-03
obredonNew Drug Application2021-09-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
allergic rhinitis perennialEFO_1001417D012221J30.89
bronchitis—D001991J40
common coldEFO_0007214D003139J00
coughHP_0012735D003371R05
laryngitis—D007827—
pharyngitis—D010612R07.0
sinusitisEFO_0007486D012852J32
whooping coughEFO_0000650D014917A37
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
38 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—10——1—11
Respiratory tract infectionsD012141J06.9—131—4
BronchitisD001991J40———123
AsthmaD001249EFO_0000270J45———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CoughD003371HP_0012735R051—2—14
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeuralgiaD009437EFO_0009430—1———1
Hiv infectionsD015658EFO_0000764B20—1———1
SinusitisD012852EFO_0007486J32—1———1
Common coldD003139EFO_0007214J00—1———1
Communicable diseasesD003141—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Therapeutic equivalencyD0138101————1
Mucociliary clearanceD0090791————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PneumoniaD011014EFO_0003106J18————11
Lung diseasesD008171EFO_0003818J98.4————11
Pulmonary fibrosisD011658J84.10————11
Back painD001416HP_0003418M54————11
InfectionsD007239EFO_0000544————11
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 class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
COc1ccccc1OCC(O)CO
Identifiers
PDB—
CAS-ID93-14-1
RxCUI5032
ChEMBL IDCHEMBL980
ChEBI ID—
PubChem CID3516
DrugBankDB00874
UNII ID495W7451VQ (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,001 documents
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Safety
Black-box Warning
Black-box warning for: Obredon
Adverse Events
Top Adverse Reactions
Mock data
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25,923 adverse events reported
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