| NDC Code | 57243-501-25 |
|---|
| Package Description | 177 mL in 1 BOTTLE (57243-501-25) |
|---|
| Product NDC | 57243-501 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Nite-time |
|---|
| Proprietary Name Suffix | Cold/flu Original |
|---|
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate |
|---|
| Dosage Form | LIQUID |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20120116 |
|---|
| Marketing Category Name | OTC MONOGRAPH DRUG |
|---|
| Application Number | M013 |
|---|
| Manufacturer | Salado Sales, Inc. |
|---|
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE |
|---|
| Strength | 650; 30; 12.5 |
|---|
| Strength Unit | mg/30mL; mg/30mL; mg/30mL |
|---|
| 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] |
|---|