"53345-006-01" National Drug Code (NDC)

Nighttime Cold And Flu 1 BAG in 1 BOX (53345-006-01) > 4000 CAPSULE, LIQUID FILLED in 1 BAG
(Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.)

NDC Code53345-006-01
Package Description1 BAG in 1 BOX (53345-006-01) > 4000 CAPSULE, LIQUID FILLED in 1 BAG
Product NDC53345-006
Product Type NameHUMAN OTC DRUG
Proprietary NameNighttime Cold And Flu
Non-Proprietary NameAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage FormCAPSULE, LIQUID FILLED
UsageORAL
Start Marketing Date20130415
Marketing Category NameOTC MONOGRAPH FINAL
Application Numberpart341
ManufacturerHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Strength325; 15; 6.25
Strength Unitmg/1; mg/1; mg/1
Pharmacy ClassesAntihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]

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