NDC Code | 55629-016-01 |
Package Description | 48 POUCH in 1 CARTON (55629-016-01) / 300 CAPSULE, LIQUID FILLED in 1 POUCH (55629-016-02) |
Product NDC | 55629-016 |
Product Type Name | HUMAN OTC DRUG |
Proprietary Name | Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Doxylamine Succinate |
Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Doxylamine Succinate |
Dosage Form | CAPSULE, LIQUID FILLED |
Usage | ORAL |
Start Marketing Date | 20210302 |
Marketing Category Name | OTC MONOGRAPH FINAL |
Application Number | part341 |
Manufacturer | ONE2ZEE LIMITED LIABILITY COMPANY |
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] |