FDA-Drug2020-04-01Class II

Ibuprofen 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

Glaxosmithkline Consumer Healthcare Holdings
Hazard

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

Sold states
Product was distributed throughout the United States, including Puerto Rico.
Affected count
471,024 blisters
Manufactured in
184 Liberty Corner Rd, N/A, Warren, NJ, United States
Products
Ibuprofen 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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1065-2020

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