MedPath

Guaifenesin

Generic Name
Guaifenesin
Brand Names
Broncotron, Bronkaid, Cheracol D, Cheratussin, Cheratussin Dac, Codar Gf, Coricidin Hbp Chest Congestion, DM, Deconex, Delsym Cough Plus Chest Congestion DM, Despec Reformulated Jun 2008, Diabetic Tussin DM, Diabetic Tussin EX, Diphen, Entex Lq, Entex T, G-zyncof, Gilphex, M-clear Wc, Mar-cof Cg, Mucinex, Mucinex Children's Cough, Mucinex Cough, Mucinex D, Mucinex DM, Mucinex Stuffy Nose & Cold, Ninjacof Xg, Obredon, Pediacare Children's Cough and Congestion, Refenesen, Refenesen PE, Rescon-GG, Robafen, Robafen DM, Robitussin Chest Congestion, Robitussin Cough & Congestion, Robitussin Maximum Strength Cough Plus Chest Congestion DM, Safetussin DM, Scot-tussin, Scot-tussin DM, Siltussin, Tusnel C, Tusnel Diabetic
Drug Type
Small Molecule
Chemical Formula
C10H14O4
CAS Number
93-14-1
Unique Ingredient Identifier
495W7451VQ

Overview

Guaifenesin possesses a storied history, having been originally formally approved by the US FDA in 1952 and continues to be one of very few - if not perhaps the only drug that is readily available and used as an expectorant . Since that time the agent has been a combination component of various prescription and non-prescription over-the-counter cough and cold products and is currently a widely available over-the-counter generic medication . Although it is principally believed that guaifenesin elicits an action to facilitate productive cough to manage chest congestion , it is not known whether the agent can reliably mitigate coughing. Regardless, on March 1, 2007, the FDA received a petition asking the FDA to notify the public that some antitussives, expectorants, decongestants, antihistamines, and cough/cold combinations are not known to be safe and effective in children under the age of 6 years . After the negotiation between FDA and major manufacturers, a voluntary transition of labels for not using guaifenesin in children under the age of 4 years was endorsed by FDA in 2008 . Furthermore, there has also been contemporary research to suggest that guaifenesin possesses and is capable of demonstrating anticonvulsant and muscle relaxant effects to some degree possibly by acting as an NMDA receptor antagonist .

Background

Guaifenesin possesses a storied history, having been originally formally approved by the US FDA in 1952 and continues to be one of very few - if not perhaps the only drug that is readily available and used as an expectorant . Since that time the agent has been a combination component of various prescription and non-prescription over-the-counter cough and cold products and is currently a widely available over-the-counter generic medication . Although it is principally believed that guaifenesin elicits an action to facilitate productive cough to manage chest congestion , it is not known whether the agent can reliably mitigate coughing. Regardless, on March 1, 2007, the FDA received a petition asking the FDA to notify the public that some antitussives, expectorants, decongestants, antihistamines, and cough/cold combinations are not known to be safe and effective in children under the age of 6 years . After the negotiation between FDA and major manufacturers, a voluntary transition of labels for not using guaifenesin in children under the age of 4 years was endorsed by FDA in 2008 . Furthermore, there has also been contemporary research to suggest that guaifenesin possesses and is capable of demonstrating anticonvulsant and muscle relaxant effects to some degree possibly by acting as an NMDA receptor antagonist .

Indication

Guaifenesin is an expectorant that is indicated for providing temporary symptomatic relief from congested chests and coughs which may be due to a cold, bronchitis, and/or other breathing illnesses .

Associated Conditions

  • Allergic Reaction
  • Allergy to Tree Pollen
  • Asthma
  • Asthma, Allergic
  • Bronchial Asthma
  • Bronchitis
  • Bronchospasm
  • Chronic Bronchitis
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Common Cold
  • Cough
  • Cough caused by Common Cold
  • Coughing caused by Allergies
  • Coughing caused by Flu caused by Influenza
  • Drug Allergy
  • Emphysema
  • Fever
  • Flu caused by Influenza
  • Food Allergy
  • Headache
  • House dust allergy
  • Irritative cough
  • Laryngitis
  • Nasal Congestion
  • Nasal Congestion caused by Common Cold
  • Phlegm
  • Productive cough
  • Rash
  • Rhinorrhoea
  • Sneezing
  • Sore Throat
  • Tracheitis
  • Urticaria
  • Whooping Cough
  • Acute Rhinitis
  • Chest congestion
  • Chills occurring with fever
  • Dry cough
  • Excess mucus or phlegm
  • Mild to moderate pain
  • Minor aches and pains

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2018/10/15
Phase 1
Completed
2018/08/28
Phase 1
Completed
2018/08/23
Phase 1
Completed
2018/08/23
Phase 1
Completed
2018/08/22
Phase 1
Completed
2018/08/16
Phase 1
Completed
2017/07/11
Phase 1
Completed
2016/09/16
N/A
Completed
2016/08/26
N/A
Completed
2016/08/09
Not Applicable
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
AMERISOURCE BERGEN
46122-750
ORAL
600 mg in 1 1
4/22/2025
Family Dollar (FAMILY WELLNESS)
55319-733
ORAL
1200 mg in 1 1
2/24/2025
Walgreen Company
0363-8005
ORAL
400 mg in 20 mL
4/25/2025
Efficient Laboratories Inc.
58593-255
ORAL
100 mg in 5 mL
6/18/2025
OPMX LLC
69729-069
ORAL
100 mg in 5 mL
5/15/2025
Meijer Distribution Inc
41250-436
ORAL
600 mg in 1 1
5/7/2025
Innovida Pharmaeutique Corporation
71800-059
ORAL
100 mg in 5 mL
6/18/2025
LABORATORIO MAGNACHEM INTERNATIONAL SRL
65131-100
ORAL
400 mg in 10 mL
3/23/2025
OPMX LLC
69729-035
ORAL
100 mg in 5 mL
5/15/2025
The Procter & Gamble Manufacturing Company
69423-810
ORAL
200 mg in 15 mL
4/9/2025

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
WOODS’ PEPPERMINT COUGH SYRUP FOR CHILDREN 50MG/5ML
SIN15653P
LIQUID
50 mg/5 ml
3/29/2019
MUCINEX EXTENDED RELEASE TABLETS 600MG
SIN14588P
TABLET, EXTENDED RELEASE
600MG
8/13/2014
COFEN 100 COUGH MIXTURE 100 mg/5 ml
SIN07957P
SYRUP
100 mg/5 ml
12/9/1994
ROBITUSSIN EX SYRUP 200 mg/10 ml
Olic (Thailand) Limited
SIN12140P
SYRUP
200 mg/10 ml
12/2/2002
GUAFENSIN SYRUP 20MG/ML
SIN14283P
SYRUP
20mg/ml
12/31/2012
ALCOUGH MIXTURE
SIN03387P
SOLUTION
50mg/5ml
6/21/1989
BREACOL COUGH SYRUP 100 mg/5 ml
SIN08411P
SYRUP
100 mg/5 ml
11/2/1995
COUGH RELIEF SYRUP 100 mg/5 ml
SIN08969P
SYRUP
100 mg/ 5 ml
10/21/1996
WOODS' PEPPERMINT COUGH SYRUP 100 mg/5 ml
SIN06725P
SYRUP
100 mg /5ml
12/13/1991
COFEN 50 COUGH MIXTURE 50 mg/5 ml
SIN08785P
SYRUP
50 mg/5 ml
7/3/1996

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Guaifenesine Syrup
国药准字H11022321
化学药品
糖浆剂
6/24/2020
Guaifenesin Granules
国药准字H61022877
化学药品
颗粒剂
3/14/2023
Guaifenesin Granules
国药准字H41024705
化学药品
颗粒剂
7/23/2020
Guaifenesin Tablets
国药准字H14022723
化学药品
片剂
8/31/2020
Guaifenesin Tablets
国药准字H44024725
化学药品
片剂
11/22/2019
Guaifenesin Tablets
国药准字H13024044
化学药品
片剂
9/28/2020
Guaifenesin Tablets
国药准字H13024043
化学药品
片剂
5/25/2020
Guaifenesin Tablets
国药准字H20054099
化学药品
片剂
4/16/2020
Guaifenesin Tablets
国药准字H62021188
化学药品
片剂
1/10/2020
Guaifenesin Tablets
国药准字H15021262
化学药品
片剂
7/20/2020
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