| NDC Code | 80513-304-50 |
|---|
| Package Description | 50 CAPSULE, LIQUID FILLED in 1 BOTTLE (80513-304-50) |
|---|
| Product NDC | 80513-304 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Nighttime Cold And Flu Relief |
|---|
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hydrobromide, And Doxylamine Succinate |
|---|
| Dosage Form | CAPSULE, LIQUID FILLED |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20240301 |
|---|
| Marketing Category Name | OTC MONOGRAPH DRUG |
|---|
| Application Number | M012 |
|---|
| Manufacturer | Advanced Rx LLC |
|---|
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE |
|---|
| Strength | 325; 15; 6.25 |
|---|
| Strength Unit | mg/1; mg/1; mg/1 |
|---|
| Pharmacy Classes | 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] |
|---|