Two medicines, side by side
Pseudoephedrine vs guaifenesin
Pseudoephedrine and guaifenesin are both labeled for cough and cold. Drugs@FDA records approvals of pseudoephedrine since 1975 and of guaifenesin since 2002. Pharmacies paid $0.281 per pseudoephedrine ER 120 mg tablet and $0.284 per ft mucus relief ER 600 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, pseudoephedrine is an alpha-adrenergic agonist and guaifenesin an expectorant.
Check it at the source: the pseudoephedrine FDA label on DailyMed (effective October 30, 2025); the guaifenesin FDA label on DailyMed (effective May 27, 2026).
Highlights of the pseudoephedrine record
Pseudoephedrine (Novafed) · label of October 30, 2025
Used for
From the label: indications• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • temporarily relieves sinus congestion and pressure
On the market
- Earliest approval on file
- August 29, 1975
- Generic labelers
- 34 labelers
- Pharmacy cost
- $0.281 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 3
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
Source: FDA drug labels via openFDA (Pseudoephedrine label of October 30, 2025, Guaifenesin label of May 27, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do pseudoephedrine and guaifenesin differ on the record?
In FDA's classes, pseudoephedrine is an alpha-adrenergic agonist and guaifenesin an expectorant.
Generics: pseudoephedrine since 1991; guaifenesin since 2011 (Drugs@FDA).
| Pseudoephedrine | Guaifenesin | |
|---|---|---|
| Labeled for | Cough and cold | Cough and cold |
| Pharmacologic class | alpha-Adrenergic Agonist | Expectorant |
| How it works (label) | n/a | n/a |
| Half-life (label) | n/a | n/a |
| Earliest approval on file (Drugs@FDA) | August 29, 1975 | July 12, 2002 |
| First generic approved | October 31, 1991 | November 23, 2011 |
| Generic labelers (NDC) | 34 labelers | 91 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.281 per tablet (Pseudoephedrine ER 120 mg tablet) | $0.284 per tablet (Ft mucus relief ER 600 mg tablet) |
| 12-month price change | +5% | -11% |
| Boxed warning | No | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 3 | 6 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 11,123 | 30,329 |
| 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 pseudoephedrine
- every medicine labeled for the same conditions