Over-the-counter medicine
Ibuprofen and pseudoephedrine Brand names: Advil; first approved as Advil Cold And Sinus
Ibuprofen and pseudoephedrine (Advil) is an over-the-counter medicine with an FDA approval on record since 1989. FDA's NDC Directory lists it from 9 generic labelers.
- Generic listed
- Over the counter
Check it at the source: the ibuprofen and pseudoephedrine FDA label on DailyMed (effective July 29, 2026, Haleon US Holdings LLC); the NDA 19771 record on Drugs@FDA; every ibuprofen and pseudoephedrine label on DailyMed.
Highlights of the record
FDA label of July 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagetemporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains
Forms and strengths
- 200 mg / 30 mg
Liquid-filled capsule; coated tablet; sugar-coated tablet.
On the market
- Earliest approval on file
- September 19, 1989 Advil Cold And Sinus, Haleon Us Holdings; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first April 17, 2001; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 9 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,338 through July 30, 2026
What is ibuprofen and pseudoephedrine used for?
From the label: indications and usagetemporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains
Conditions named in the indications of ibuprofen and pseudoephedrine's FDA labels, with every medicine labeled for each:
From other ibuprofen and pseudoephedrine labelsCough and cold: Uses temporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains
FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug and alpha-Adrenergic Agonist.
Source: FDA drug label (ADVIL COLD AND SINUS), Haleon US Holdings LLC, effective July 29, 2026 (SPL set 0da9ed22-bfb4-d61b-110b-0c7760332a98), via openFDA; the full label on DailyMed
Is there a generic for ibuprofen and pseudoephedrine (Advil)?
The FDA approved the first generic ibuprofen and pseudoephedrine on April 17, 2001. 6 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ibuprofen and pseudoephedrine from 9 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1989 earliest approval on file
- 2001 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ibuprofen and pseudoephedrine label say about other medicines?
The ibuprofen and pseudoephedrine label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | warnings | Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. |
| Naproxen | warnings | The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this … |
Source: FDA drug label (ADVIL COLD AND SINUS), Haleon US Holdings LLC, effective July 29, 2026 (SPL set 0da9ed22-bfb4-d61b-110b-0c7760332a98), via openFDA; the full label on DailyMed
What do FAERS reports show for ibuprofen and pseudoephedrine?
The FDA Adverse Event Reporting System holds 1,338 reports that list ibuprofen and pseudoephedrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 14 are coded as a death and 128 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ibuprofen and pseudoephedrine?
14 other medicines are given the same way (oral) and in the same FDA class as ibuprofen and pseudoephedrine or labeled mainly for the same use (cough and cold), the same class first. Cough and cold lists all 31 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Naproxen | Cough and cold | 146 labelers | $0.0565 per tablet 500 mg tablet | No current entry |
| Acetaminophen and aspirin and caffeine | Cough and cold | 39 labelers | $0.0648 per unit 250-250-65 mg cplt | No current entry |
| Diphenhydramine | Cough and cold | 4 labelers | $0.0185 per mL 12.5 mg/5 mL | No current entry |
| Dextromethorphan and guaifenesin | Cough and cold | 61 labelers | $0.0207 per mL 200-20 mg/20 mL | No current entry |
| Guaifenesin | Cough and cold | 102 labelers | $0.284 per tablet 600 mg tablet | No current entry |
| Benzonatate | Cough and cold | 45 labelers | $0.0656 per capsule 100 mg capsule | No current entry |
| Dextromethorphan | Cough and cold | 28 labelers | $0.122 per unit 15 mg softgel | No current entry |
| Phenylephrine | Cough and cold | none listed | $0.0496 per tablet 10 mg tablet | No current entry |
Every medicine labeled for the same conditions as ibuprofen and pseudoephedrine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ibuprofen and pseudoephedrine
- 14 medicines for the same use
- Other NSAIDs
- the pharmacologic class, with prices and generics
- Ibuprofen and pseudoephedrine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other