NDC Code | 51013-175-04 |
Package Description | 2 BLISTER PACK in 1 CARTON (51013-175-04) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
Product NDC | 51013-175 |
Product Type Name | HUMAN OTC DRUG |
Proprietary Name | Night Time Severe Cold And Flu Relief |
Non-Proprietary Name | Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate, Dextromethorphan Hydrobromide |
Dosage Form | CAPSULE, LIQUID FILLED |
Usage | ORAL |
Start Marketing Date | 20160609 |
Marketing Category Name | OTC MONOGRAPH FINAL |
Application Number | part341 |
Manufacturer | PuraCap Pharmaceutical LLC |
Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE |
Strength | 325; 10; 6.25; 5 |
Strength Unit | mg/1; mg/1; mg/1; mg/1 |
Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], Antihistamine [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], alpha-1 Adrenergic Agonist [EPC] |