| NDC Code | 36800-872-40 |
|---|
| Package Description | 355 mL in 1 BOTTLE (36800-872-40) |
|---|
| Product NDC | 36800-872 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Topcare Nite Time |
|---|
| Proprietary Name Suffix | Cold And Flu Relief |
|---|
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate |
|---|
| Dosage Form | SOLUTION |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20120717 |
|---|
| Marketing Category Name | OTC MONOGRAPH FINAL |
|---|
| Application Number | part341 |
|---|
| Manufacturer | Topco Associates LLC |
|---|
| 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] |
|---|