FDA-Drug2016-09-28Class III

Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60

Reckitt Benckiser LLC
Hazard

Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Also, quantity is incorrectly stated as 30 daytime and 30 nighttime instead of 36 daytime and 24 nighttime.

Sold states
FL, MA and NJ
Affected count
738 boxes
Manufactured in
399 Interpace Pkwy, Parsippany, NJ, United States
Products
Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1517-2016

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