Guaifenesin
Tablet, Extended Release · Oral
Active ingredient
Active ingredient ( in each extended-release tablet) Guaifenesin USP 1200 mg
Purpose
Purpose Expectorant
Uses
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warnings
Warnings Do not use for children under 12 years of age
Ask a doctor before use
Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus)
Stop use and ask a doctor
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
Pregnancy or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
Directions do not crush, chew, or break extended-release tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children 12 years of age and over: 1 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours children under 12 years of age: do not use
Other information
Other information store between 20° to 25°C (68° to 77°F)
Inactive ingredients
Inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinised starch (maize)
Questions?
Questions? 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC. 279 Princeton-Hightstown Road, East Windsor, NJ 08520 Made in India
Label text from the FDA structured product label by Aurohealth LLC (revised Jul 3, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Guaifenesin in 66 products
Guaifenesin NDC products (66)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 80513-413 | Guaifenesin 1200 mg/1 Tablet, Extended Release | Advanced Rx LLC | ANDA |
| 46122-750 | Guaifenesin 600 mg/1 Tablet, Extended Release | AMERISOURCE BERGEN | ANDA |
| 65162-037 | Guaifenesin 1200 mg/1 Tablet, Extended Release | Amneal Pharmaceuticals LLC | ANDA |
| 65162-036 | Guaifenesin 600 mg/1 Tablet, Extended Release | Amneal Pharmaceuticals LLC | ANDA |
| 58602-865 | Guaifenesin 1200 mg/1 Tablet, Extended Release | Aurohealth LLC | ANDA |
| 58602-810 | Guaifenesin 600 mg/1 Tablet, Extended Release | Aurohealth LLC | ANDA |
| 58602-811 | Guaifenesin 1200 mg/1 Tablet, Extended Release | Aurohealth LLC | ANDA |
| 58602-853 | Guaifenesin 600 mg/1 Tablet, Extended Release | Aurohealth LLC | ANDA |
| 58602-857 | Guaifenesin 1200 mg/1 Tablet, Extended Release | Aurohealth LLC | ANDA |
| 58602-864 | Guaifenesin 600 mg/1 Tablet, Extended Release | Aurohealth LLC | ANDA |
| 21130-179 | Guaifenesin 600 mg/1 Tablet, Extended Release | Better Living Brands LLC | ANDA |
| 68001-561 | Guaifenesin 600 mg/1 Tablet, Extended Release | BluePoint Laboratories | ANDA |
| 51316-071 | Guaifenesin 600 mg/1 Tablet, Extended Release | CVS | ANDA |
| 69842-335 | Guaifenesin 1200 mg/1 Tablet, Extended Release | CVS PHARMACY, INC | ANDA |
| 62207-839 | Guaifenesin 600 mg/1 Tablet, Extended Release | Granules India Ltd | ANDA |
| 62207-570 | Guaifenesin 600 mg/1 Tablet, Extended Release | Granules India Ltd | ANDA |
| 62207-569 | Guaifenesin 1200 mg/1 Tablet, Extended Release | Granules India Ltd | ANDA |
| 62207-840 | Guaifenesin 1200 mg/1 Tablet, Extended Release | Granules India Ltd | ANDA |
| 70010-199 | Guaifenesin 600 mg/1 Tablet, Extended Release | GRANULES PHARMACEUTICALS INC. | ANDA |
| 69848-017 | Guaifenesin 600 mg/1 Tablet, Extended Release | GRANULES USA, INC. | ANDA |
| 69848-018 | Guaifenesin 1200 mg/1 Tablet, Extended Release | GRANULES USA, INC. | ANDA |
| 30142-961 | Guaifenesin 600 mg/1 Tablet, Extended Release | Kroger Company | ANDA |
| 30142-962 | Guaifenesin 1200 mg/1 Tablet, Extended Release | Kroger Company | ANDA |
| 51660-566 | Guaifenesin 600 mg/1 Tablet, Extended Release | Ohm Laboratories, Inc. | ANDA |
| 51660-567 | Guaifenesin 1200 mg/1 Tablet, Extended Release | Ohm Laboratories, Inc. | ANDA |
| 82804-265 | Guaifenesin 600 mg/1 Tablet, Extended Release | Proficient Rx LP | ANDA |
| 41415-997 | Guaifenesin 1200 mg/1 Tablet, Extended Release | PUBLIX SUPER MARKETS, INC | ANDA |
| 41415-996 | Guaifenesin 600 mg/1 Tablet, Extended Release | Publix Super Markets, Inc | ANDA |
| 11822-4260 | Guaifenesin 1200 mg/1 Tablet, Extended Release | RITE AID CORPORATION | ANDA |
| 21130-554 | Guaifenesin 1200 mg/1 Tablet | Safeway, Inc | ANDA |
| 71309-461 | Guaifenesin 1200 mg/1 Tablet, Extended Release | Safrel Pharmaceuticals, LLC. | ANDA |
| 68196-996 | Guaifenesin 1200 mg/1 Tablet, Extended Release | SAM'S WEST INC | ANDA |
| 68196-960 | Guaifenesin 1200 mg/1 Tablet, Extended Release | Sam's West Inc | ANDA |
| 68196-405 | Guaifenesin 1200 mg/1 Tablet | SAM'S WEST INC | ANDA |
| 11673-539 | Guaifenesin 600 mg/1 Tablet | TARGET CORPORATION | ANDA |
| 11673-840 | Guaifenesin 1200 mg/1 Tablet | TARGET CORPORATION | ANDA |
| 76162-031 | Guaifenesin 1200 mg/1 Tablet, Extended Release | TOPCO ASSOCIATES LLC | ANDA |
| 71179-002 | Guaifenesin 1200 mg/1 Tablet, Extended Release | VESPYR BRANDS LLC | ANDA |
| 0363-0033 | Guaifenesin 1200 mg/1 Tablet, Extended Release | WALGREEN CO. | ANDA |
| 0363-0028 | Guaifenesin 600 mg/1 Tablet, Extended Release | WALGREEN CO. | ANDA |
| 0363-9569 | Guaifenesin 600 mg/1 Tablet | Walgreens | ANDA |
| 0363-0570 | Guaifenesin 1200 mg/1 Tablet | Walgreens | ANDA |
| 79903-124 | Guaifenesin 600 mg/1 Tablet, Extended Release | Walmart Stores, Inc. | ANDA |
| 73581-400 | Guaifenesin 600 mg/1 Tablet | YYBA CORP | ANDA |
| 14803-162 | Guaifenesin 400 mg/1 Tablet | Elysium Pharmaceuticals Ltd. | DRUG FOR FURTHER PROCESSING |
| 60687-874 | Guaifenesin 300 mg/15mL Solution | American Health Packaging | OTC MONOGRAPH DRUG |
| 60687-863 | Guaifenesin 200 mg/10mL Solution | American Health Packaging | OTC MONOGRAPH DRUG |
| 60687-852 | Guaifenesin 100 mg/5mL Solution | American Health Packaging | OTC MONOGRAPH DRUG |
| 24689-144 | Guaifenesin 400 mg/1 Tablet | APNAR PHARMA LP | OTC MONOGRAPH DRUG |
| 71335-9616 | Guaifenesin 400 mg/1 Tablet | Bryant Ranch Prepack | OTC MONOGRAPH DRUG |
| 72162-2278 | Guaifenesin 100 mg/5mL Liquid | Bryant Ranch Prepack | OTC MONOGRAPH DRUG |
| 55154-5780 | Guaifenesin 200 mg/10mL Solution | Cardinal Health 107, LLC | OTC MONOGRAPH DRUG |
| 55154-9450 | Guaifenesin 100 mg/5mL Solution | Cardinal Health 107, LLC | OTC MONOGRAPH DRUG |
| 71679-309 | Guaifenesin 400 mg/1 Tablet | Health Pharma USA LLC | OTC MONOGRAPH DRUG |
| 81033-102 | Guaifenesin 100 mg/5mL Liquid | KESIN PHARMA CORPORATION | OTC MONOGRAPH DRUG |
| 0904-5154 | Guaifenesin 200 mg/1 Tablet | Major Pharmaceuticals | OTC MONOGRAPH DRUG |
| 58657-509 | Guaifenesin 100 mg/5mL Liquid | Method Pharmaceuticals, LLC | OTC MONOGRAPH DRUG |
| 58657-508 | Guaifenesin 100 mg/5mL Liquid | Method Pharmaceuticals, LLC | OTC MONOGRAPH DRUG |
| 83720-503 | Guaifenesin 100 mg/5mL Liquid | Oncor Pharmaceuticals | OTC MONOGRAPH DRUG |
| 0121-2232 | Guaifenesin 300 mg/15mL Solution | PAI Holdings, LLC dba PAI Pharma | OTC MONOGRAPH DRUG |
| 0121-1744 | Guaifenesin 100 mg/5mL Solution | PAI Holdings, LLC dba PAI Pharma | OTC MONOGRAPH DRUG |
| 0121-1488 | Guaifenesin 200 mg/10mL Solution | PAI Holdings, LLC dba PAI Pharma | OTC MONOGRAPH DRUG |
| 0121-0744 | Guaifenesin 100 mg/5mL Solution | PAI Holdings, LLC dba PAI Pharma | OTC MONOGRAPH DRUG |
| 16103-379 | Guaifenesin 400 mg/1 Tablet | Pharbest Pharmaceuticals, Inc. | OTC MONOGRAPH DRUG |
| 69618-061 | Guaifenesin 400 mg/1 Tablet | Reliable 1 Laboratories LLC | OTC MONOGRAPH DRUG |
| 81993-002 | Guaifenesin 200 mg/1 Tablet | Zennova LLC | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Guaifenesin used for?
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Who makes Guaifenesin?
Guaifenesin is listed by 42 labelers in the FDA NDC directory, including Advanced Rx LLC, AMERISOURCE BERGEN, Amneal Pharmaceuticals LLC, Aurohealth LLC.