| NDC Code | 50580-450-01 |
|---|
| Package Description | 2 BLISTER PACK in 1 CARTON (50580-450-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK |
|---|
| Product NDC | 50580-450 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Sudafed Pe Head Congestion Plus Flu Severe |
|---|
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride |
|---|
| Dosage Form | TABLET, FILM COATED |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20190617 |
|---|
| Marketing Category Name | OTC MONOGRAPH DRUG |
|---|
| Application Number | M012 |
|---|
| Manufacturer | Kenvue Brands LLC |
|---|
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
|---|
| Strength | 325; 10; 100; 5 |
|---|
| Strength Unit | mg/1; mg/1; mg/1; mg/1 |
|---|
| Pharmacy Classes | Adrenergic alpha1-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-1 Adrenergic Agonist [EPC] |
|---|