Two medicines, side by side
Pseudoephedrine vs ibuprofen
Pseudoephedrine and ibuprofen are both labeled for cough and cold. Drugs@FDA records approvals of pseudoephedrine since 1975 and of ibuprofen since 1974. Pharmacies paid $0.281 per pseudoephedrine ER 120 mg tablet and $0.0573 per ibuprofen 800 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 ibuprofen a nonsteroidal anti-inflammatory drug.
Check it at the source: the pseudoephedrine FDA label on DailyMed (effective October 30, 2025); the ibuprofen FDA label on DailyMed (effective January 1, 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 ibuprofen record
Ibuprofen (Advil) · label of January 1, 2026
Used for
From the label: indications■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ minor pain of arthritis ■ toothache ■ backache ■ the common cold ■ menstrual cramps ■ temporarily reduces fever
On the market
- Earliest approval on file
- September 19, 1974
- Generic labelers
- 245 labelers
- Pharmacy cost
- $0.0573 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 40
Source: FDA drug labels via openFDA (Pseudoephedrine label of October 30, 2025, Ibuprofen label of January 1, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do pseudoephedrine and ibuprofen differ on the record?
In FDA's classes, pseudoephedrine is an alpha-adrenergic agonist and ibuprofen a nonsteroidal anti-inflammatory drug.
Only the ibuprofen label carries a boxed warning.
Generics: pseudoephedrine since 1991; ibuprofen since 1985 (Drugs@FDA).
| Pseudoephedrine | Ibuprofen | |
|---|---|---|
| Labeled for | Cough and cold | Fever, Osteoarthritis, Rheumatoid arthritis, Pain, Cough and cold |
| Pharmacologic class | alpha-Adrenergic Agonist | Nonsteroidal Anti-inflammatory Drug |
| How it works (label) | n/a | n/a |
| Half-life (label) | n/a | n/a |
| Earliest approval on file (Drugs@FDA) | August 29, 1975 | September 19, 1974 |
| First generic approved | October 31, 1991 | February 8, 1985 |
| Generic labelers (NDC) | 34 labelers | 245 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.281 per tablet (Pseudoephedrine ER 120 mg tablet) | $0.0573 per tablet (Ibuprofen 800 mg tablet) |
| 12-month price change | +5% | -2% |
| Boxed warning | No | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 3 | 40 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 11,123 | 270,516 |
| 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 do the labels say about using others of their kind?
Ibuprofen label, drug interactions (prescription label)The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of ibuprofen and aspirin is not generally recommended because of the potential for increased adverse effects.
Source: FDA drug labels via openFDA
What next?
- Alternatives to pseudoephedrine
- every medicine labeled for the same conditions