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Class II · ModerateRecall completed

Advil Allergy And Congestion Relief

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberBatch/Lot Numbers: R73995, exp. date 07/31/2021 R53915, exp. date 05/31/2020 9324HA, exp. date 07/31/2021 9327HA, exp. date 07/31/2021
Where it was soldProduct was distributed throughout the United States, including Puerto Rico.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byHaleon US Holdings LLC
Brand nameADVIL ALLERGY AND CONGESTION RELIEF
Generic nameCHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE
Active ingredient(s)CHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE
Distributed by / forGlaxosmithkline Consumer Healthcare Holdings
NDC0573-0196-10
Show the full FDA record
Full product labelIbuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count blister tray in carton NDC 0573-0196-10, item # F00573019610C, 10 ct. blister NDC 0573-0196-20, item # F00573019620C, 20 ct. blister NDC 0573-0196-10, item # F00573019610R, 10 ct. blister
Recalling firmGlaxosmithkline Consumer Healthcare Holdings
DistributionProduct was distributed throughout the United States, including Puerto Rico.
Quantity471,024 blisters
Recall initiated2020-03-16
Report date2020-04-01
Recall completed2021-10-28
Recall numberD-1065-2020
ClassificationClass II
FDA statusTerminated
Origin on fileWarren NJ United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.