| NDC Code | 50991-535-01 |
|---|
| Package Description | 100 TABLET in 1 BOTTLE (50991-535-01) |
|---|
| Product NDC | 50991-535 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Duraflu |
|---|
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Pseudoephedrine Hcl |
|---|
| Dosage Form | TABLET |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20151001 |
|---|
| Marketing Category Name | OTC MONOGRAPH DRUG |
|---|
| Application Number | M012 |
|---|
| Manufacturer | Poly Pharmaceuticals, Inc. |
|---|
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE |
|---|
| Strength | 325; 20; 200; 60 |
|---|
| Strength Unit | mg/1; mg/1; mg/1; mg/1 |
|---|
| Pharmacy Classes | Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC] |
|---|