| NDC Code | 53345-020-01 |
| Package Description | 1 BAG in 1 BOX (53345-020-01) / 4000 CAPSULE, LIQUID FILLED in 1 BAG |
| Product NDC | 53345-020 |
| Product Type Name | HUMAN OTC DRUG |
| Proprietary Name | Night Cold Flu Cough And Allergy |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride |
| Dosage Form | CAPSULE, LIQUID FILLED |
| Usage | ORAL |
| Start Marketing Date | 20130529 |
| Marketing Category Name | OTC MONOGRAPH DRUG |
| Application Number | M012 |
| Manufacturer | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. |
| 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] |