Over-the-counter medicine

Chlorpheniramine and ibuprofen and pseudoephedrine Brand names: Advil; first approved as Advil Allergy Sinus

Chlorpheniramine and ibuprofen and pseudoephedrine (Advil) is an over-the-counter medicine with an FDA approval on record since 2002. 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 pseudoephedrine FDA label on DailyMed (effective March 23, 2026, Haleon US Holdings LLC); the NDA 21441 record on Drugs@FDA; every chlorpheniramine and ibuprofen and pseudoephedrine label on DailyMed.

Highlights of the record

FDA label of March 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
temporarily 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 aches and pains fever

Forms and strengths

2 mg / 200 mg / 30 mg

Coated tablet.

On the market

Earliest approval on file: December 19, 2002 Advil Allergy Sinus, Haleon Us Holdings; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent: February 28, 2027 Advil Allergy Sinus tablets; not a generic launch date

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: 236 through July 30, 2026

What is chlorpheniramine and ibuprofen and pseudoephedrine used for?

From the label: indications and usage
temporarily 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 aches and pains fever

Conditions named in the indications of chlorpheniramine and ibuprofen and pseudoephedrine's FDA labels, with every medicine labeled for each:

From other chlorpheniramine and ibuprofen and pseudoephedrine labels
Allergies and Cough and cold: Uses temporarily 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 …

FDA pharmacologic class: Histamine-1 Receptor Antagonist, Nonsteroidal Anti-inflammatory Drug and alpha-Adrenergic Agonist.

Source: FDA drug label (ADVIL ALLERGY SINUS), Haleon US Holdings LLC, effective March 23, 2026 (SPL set ecd6ea11-8b34-01b4-cbd9-901ba7a8f6e2), via openFDA; the full label on DailyMed

Is there a generic for chlorpheniramine and ibuprofen and pseudoephedrine (Advil)?

No generic chlorpheniramine and ibuprofen and pseudoephedrine is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 1 patent for Advil Allergy Sinus tablets, the last expiring on February 28, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2002 earliest approval on file
2027 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the chlorpheniramine and ibuprofen and pseudoephedrine label say about other medicines?

The chlorpheniramine and 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 …

Check chlorpheniramine and ibuprofen and pseudoephedrine against other medicines

Source: FDA drug label (ADVIL ALLERGY SINUS), Haleon US Holdings LLC, effective March 23, 2026 (SPL set ecd6ea11-8b34-01b4-cbd9-901ba7a8f6e2), via openFDA; the full label on DailyMed

What do FAERS reports show for chlorpheniramine and ibuprofen and pseudoephedrine?

The FDA Adverse Event Reporting System holds 236 reports that list chlorpheniramine and ibuprofen and pseudoephedrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 3 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.

The most reported reactions

Drug Ineffective (a use or a product term, not a reaction)78
Product Use In Unapproved Indication (a use or a product term, not a reaction)30
Drug Effective For Unapproved Indication (a use or a product term, not a reaction)23
Drug Effect Incomplete13
Dizziness10
Somnolence9
Headache (a use or a product term, not a reaction)8
Insomnia8

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 pseudoephedrine?

10 other medicines are given the same way (oral) and in the same FDA class as chlorpheniramine and ibuprofen and pseudoephedrine 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
Desloratadine	Allergies	9 labelers	$0.258 per tablet 5 mg tablet	No current entry
Carbinoxamine	Allergies	7 labelers	$0.398 per tablet 4 mg tablet	No current entry

Every medicine labeled for the same conditions as chlorpheniramine and ibuprofen and pseudoephedrine

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 pseudoephedrine: 10 medicines for the same use
Other antihistamines: the pharmacologic class, with prices and generics
Chlorpheniramine and ibuprofen and pseudoephedrine side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other