| NDC Code | 55629-012-01 |
| Package Description | 48 POUCH in 1 CARTON (55629-012-01) / 300 CAPSULE, LIQUID FILLED in 1 POUCH (55629-012-02) |
| Product NDC | 55629-012 |
| Product Type Name | HUMAN OTC DRUG |
| Proprietary Name | Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride |
| Dosage Form | CAPSULE, LIQUID FILLED |
| Usage | ORAL |
| Start Marketing Date | 20210301 |
| Marketing Category Name | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Manufacturer | ONE2ZEE LIMITED LIABILITY COMPANY |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Strength | 325; 10; 5 |
| Strength Unit | mg/1; mg/1; mg/1 |
| Pharmacy Classes | Adrenergic alpha1-Agonists [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] |