FDA-Drug2020-02-19Class II

Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton. Distributed by: GSK Consumer Healthcare, Warren, NJ 07059. NDC carton: 0067-6089-01, NDC packet: 0067-6089-03

GSK Consumer Health, Inc
Hazard

Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the product label, Ask a doctor before use if you have a sodium-restricted diet.

Sold states
Distributed Nationwide in the USA
Affected count
431,614 cartons
Manufactured in
10401 Hwy 6, Lincoln, NE, United States
Products
Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton. Distributed by: GSK Consumer Healthcare, Warren, NJ 07059. NDC carton: 0067-6089-01, NDC packet: 0067-6089-03

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0996-2020

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