Two medicines, side by side
Pseudoephedrine vs acetaminophen
Pseudoephedrine and acetaminophen are both labeled for cough and cold. Drugs@FDA records approvals of pseudoephedrine since 1975 and of acetaminophen since 1968. Pharmacies paid $0.281 per pseudoephedrine ER 120 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 pseudoephedrine FDA label on DailyMed (effective October 30, 2025); the acetaminophen FDA label on DailyMed (effective November 13, 2024).
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 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 (Pseudoephedrine label of October 30, 2025, Acetaminophen label of November 13, 2024); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do pseudoephedrine and acetaminophen differ on the record?
Only the acetaminophen label carries a boxed warning.
Generics: pseudoephedrine since 1991; acetaminophen since 1986 (Drugs@FDA).
| Pseudoephedrine | Acetaminophen | |
|---|---|---|
| Labeled for | Cough and cold | Fever, Cough and cold, Pain |
| Pharmacologic class | alpha-Adrenergic Agonist | n/a |
| How it works (label) | n/a | n/a |
| Half-life (label) | n/a | n/a |
| Earliest approval on file (Drugs@FDA) | August 29, 1975 | November 7, 1968 |
| First generic approved | October 31, 1991 | December 1, 1986 |
| Generic labelers (NDC) | 34 labelers | 89 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.281 per tablet (Pseudoephedrine ER 120 mg tablet) | $0.0339 per unit (Acetaminophen 500 mg caplet) |
| 12-month price change | +5% | +5% |
| Boxed warning | No | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 3 | 19 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 11,123 | 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 pseudoephedrine
- every medicine labeled for the same conditions