Two medicines, side by side
Guaifenesin vs acetaminophen
Guaifenesin and acetaminophen are both labeled for cough and cold. Drugs@FDA records approvals of guaifenesin since 2002 and of acetaminophen since 1968. Pharmacies paid $0.284 per ft mucus relief ER 600 mg tablet and $0.0339 per unit (Acetaminophen 500 mg caplet) (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. Only the acetaminophen label carries a boxed warning.
Check it at the source: the guaifenesin FDA label on DailyMed (effective May 27, 2026); the acetaminophen FDA label on DailyMed (effective November 13, 2024).
Highlights of the guaifenesin record
Guaifenesin (Mucinex) · label of May 27, 2026
Used for
From the label: indicationshelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
On the market
- Earliest approval on file
- July 12, 2002
- Generic labelers
- 91 labelers
- Pharmacy cost
- $0.284 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 6
Highlights of the acetaminophen record
Acetaminophen (Tylenol) · label of November 13, 2024
Used for
From the label: indicationstemporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever
On the market
- Earliest approval on file
- November 7, 1968
- Generic labelers
- 89 labelers
- Pharmacy cost
- $0.0339 per unit
Supply and safety
- Shortage
- No current entry
- Recalls
- 19
Source: FDA drug labels via openFDA (Guaifenesin label of May 27, 2026, Acetaminophen label of November 13, 2024); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do guaifenesin and acetaminophen differ on the record?
Only the acetaminophen label carries a boxed warning.
Generics: guaifenesin since 2011; acetaminophen since 1986 (Drugs@FDA).
| Guaifenesin | Acetaminophen | |
|---|---|---|
| Labeled for | Cough and cold | Fever, Cough and cold, Pain |
| Pharmacologic class | Expectorant | n/a |
| How it works (label) | n/a | n/a |
| Half-life (label) | n/a | n/a |
| Earliest approval on file (Drugs@FDA) | July 12, 2002 | November 7, 1968 |
| First generic approved | November 23, 2011 | December 1, 1986 |
| Generic labelers (NDC) | 91 labelers | 89 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.284 per tablet (Ft mucus relief ER 600 mg tablet) | $0.0339 per unit (Acetaminophen 500 mg caplet) |
| 12-month price change | -11% | +5% |
| Boxed warning | No | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 6 | 19 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 30,329 | 445,075 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What next?
- Alternatives to guaifenesin
- every medicine labeled for the same conditions