| NDC Code | 80513-301-50 |
|---|
| Package Description | 50 CAPSULE, GELATIN COATED in 1 BOTTLE (80513-301-50) |
|---|
| Product NDC | 80513-301 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Daytime Cold And Flu Relief Softgels |
|---|
| Proprietary Name Suffix | Non-drowsy |
|---|
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr, Phenylephrine |
|---|
| Dosage Form | CAPSULE, GELATIN COATED |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20230424 |
|---|
| Marketing Category Name | OTC MONOGRAPH DRUG |
|---|
| Application Number | M012 |
|---|
| Manufacturer | Advanced Rx LLC |
|---|
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DIPHENHYDRAMINE HYDROCHLORIDE |
|---|
| Strength | 325; 10; 5 |
|---|
| Strength Unit | mg/1; mg/1; mg/1 |
|---|
| Pharmacy Classes | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
|---|