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 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
GUAIAPHEN SYRUP 100MG/5ML | N/A | N/A | N/A | 6/19/1979 | |
THURAMIN COUGH SYRUP | N/A | N/A | N/A | 7/28/2001 | |
VIDA TUSSIN-DM SYRUP | N/A | N/A | N/A | 10/28/2008 | |
UNI-CODPLEX SYRUP | N/A | N/A | N/A | 12/14/1998 | |
COCO COUGH SYRUP | N/A | N/A | N/A | 9/19/2001 | |
COUGH-VIT SYRUP | N/A | N/A | N/A | 4/30/2007 | |
DEXSIN SYRUP | N/A | N/A | N/A | 6/26/2000 | |
CODOLAX COMPLEX SYRUP | N/A | N/A | N/A | 5/25/1979 | |
NEW COLD STOP FLU & COUGH CAP | N/A | N/A | N/A | 8/5/2007 | |
ADVATUSIN COUGH SUSPENSION | N/A | N/A | N/A | 12/30/2000 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
VICKS FORMULA 44 FOR CHESTY COUGHS guaifenesin 13.33mg/mL oral liquid bottle | 91691 | Medicine | A | 11/7/2002 | |
DURO-TUSS CHESTY COUGH TABLETS FORTE tablet blister pack | 210274 | Medicine | A | 5/30/2013 | |
VICKS COUGH SYRUP HONEY FLAVOUR FOR CHESTY COUGH FOR CHILDREN 6 YEARS AND OVER guaifenesin 13.33 mg/mL oral liquid bottle | 133115 | Medicine | A | 11/21/2006 | |
MEDIX CHESTY COUGH MEDICINE guaifenesin 100 mg/5 mL oral liquid bottle | 190860 | Medicine | A | 10/18/2011 | |
ROBITUSSIN COUGH & CHEST CONGESTION oral liquid bottle | 13884 | Medicine | A | 8/30/1991 | |
PHARMACY ACTION DOUBLE ACTION CHESTY COUGH RELIEF oral liquid bottle | 198704 | Medicine | A | 6/25/2012 | |
ROPECT Softgel Capsule | 300634 | Medicine | A | 3/9/2018 | |
ROBITUSSIN CHESTY COUGH & NASAL CONGESTION PS oral liquid bottle | 13885 | Medicine | A | 8/30/1991 | |
TERRYWHITE CHEMMART CHESTY COUGH RELIEF DUAL ACTION oral liquid bottle | 304301 | Medicine | A | 6/14/2018 | |
CODRAL MUCUS COUGH guaifenesin 20 mg/mL oral liquid bottle | 204221 | Medicine | A | 12/19/2012 |