Over-the-counter medicine
Chlorpheniramine and ibuprofen and phenylephrine Brand names: Advil; first approved as Advil Allergy And Congestion Relief
Chlorpheniramine and ibuprofen and phenylephrine (Advil) is an over-the-counter medicine with an FDA approval on record since 2011. No generic is listed in FDA's NDC Directory.
- No generic listed
- Over the counter
Check it at the source: the chlorpheniramine and ibuprofen and phenylephrine FDA label on DailyMed (effective April 9, 2025, Haleon US Holdings LLC); the NDA 22113 record on Drugs@FDA; every chlorpheniramine and ibuprofen and phenylephrine label on DailyMed.
Highlights of the record
FDA label of April 9, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagetemporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
runny nose
itchy, watery eyes
itching of the nose or throat
sneezing
nasal congestion
sinus pressure
headache
minor body aches and pains
fever
reduces swelling of the nasal passages
temporarily restores freer breathing through the nose
Forms and strengths
- 4 mg / 200 mg / 10 mg
Coated tablet.
On the market
- Earliest approval on file
- December 21, 2011 Advil Allergy And Congestion Relief, Haleon Us Holdings; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 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)
- 1 since 2020 0 Class I among all firms' recalls; latest March 16, 2020
- FAERS reports
- 574 through July 30, 2026
What is chlorpheniramine and ibuprofen and phenylephrine used for?
From the label: indications and usagetemporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
runny nose
itchy, watery eyes
itching of the nose or throat
sneezing
nasal congestion
sinus pressure
headache
minor body aches and pains
fever
reduces swelling of the nasal passages
temporarily restores freer breathing through the nose
Conditions named in the indications of chlorpheniramine and ibuprofen and phenylephrine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Histamine-1 Receptor Antagonist, Nonsteroidal Anti-inflammatory Drug and alpha-1 Adrenergic Agonist.
Source: FDA drug label (Advil Allergy and Congestion Relief), Haleon US Holdings LLC, effective April 9, 2025 (SPL set a6cc97d8-252a-4527-a470-6d9e356342fd), via openFDA; the full label on DailyMed
Is there a generic for chlorpheniramine and ibuprofen and phenylephrine (Advil)?
No generic chlorpheniramine and ibuprofen and phenylephrine is approved (Drugs@FDA, October 8, 2026).
- 2011 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has chlorpheniramine and ibuprofen and phenylephrine been recalled?
The FDA's Enforcement Report lists 1 recall naming chlorpheniramine and ibuprofen and phenylephrine since 2020: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 16, 2020 | Class II | Glaxosmithkline Consumer Healthcare Holdings | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the chlorpheniramine and ibuprofen and phenylephrine label say about other medicines?
The chlorpheniramine and ibuprofen and phenylephrine 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 | take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] |
Check chlorpheniramine and ibuprofen and phenylephrine against other medicines
Source: FDA drug label (Advil Allergy and Congestion Relief), Haleon US Holdings LLC, effective April 9, 2025 (SPL set a6cc97d8-252a-4527-a470-6d9e356342fd), via openFDA; the full label on DailyMed
What do FAERS reports show for chlorpheniramine and ibuprofen and phenylephrine?
The FDA Adverse Event Reporting System holds 574 reports that list chlorpheniramine and ibuprofen and phenylephrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 9 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 chlorpheniramine and ibuprofen and phenylephrine?
14 other medicines are given the same way (oral) and in the same FDA class as chlorpheniramine and ibuprofen and phenylephrine or labeled mainly for the same use (allergies), the same class first. Allergies lists all 36 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 |
|---|---|---|---|---|
| Diphenhydramine | Allergies, Cough and cold | 4 labelers | $0.0185 per mL 12.5 mg/5 mL | No current entry |
| Naproxen | Cough and cold | 146 labelers | $0.0565 per tablet 500 mg tablet | No current entry |
| Cetirizine | Allergies | 164 labelers | $0.0613 per tablet 10 mg tablet | No current entry |
| Fexofenadine | Allergies | 110 labelers | $0.230 per tablet 180 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 |
| Levocetirizine | Allergies | 53 labelers | $0.0511 per tablet 5 mg tablet | No current entry |
| Fexofenadine and pseudoephedrine | Cough and cold | 27 labelers | $0.483 per tablet 60-120 tablet | No current entry |
| Desloratadine | Allergies | 9 labelers | $0.258 per tablet 5 mg tablet | No current entry |
Every medicine labeled for the same conditions as chlorpheniramine and ibuprofen and phenylephrine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to chlorpheniramine and ibuprofen and phenylephrine
- 14 medicines for the same use
- Other antihistamines
- the pharmacologic class, with prices and generics
- Chlorpheniramine and ibuprofen and phenylephrine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other