| NDC Code | 36800-291-40 |
|---|
| Package Description | 355 mL in 1 BOTTLE (36800-291-40) |
|---|
| Product NDC | 36800-291 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Topcare Nite Time Cold And Flu |
|---|
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl |
|---|
| Dosage Form | SOLUTION |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20150804 |
|---|
| Marketing Category Name | OTC MONOGRAPH DRUG |
|---|
| Application Number | M012 |
|---|
| Manufacturer | Topco Associates LLC |
|---|
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE |
|---|
| Strength | 650; 20; 12.5; 10 |
|---|
| Strength Unit | mg/30mL; mg/30mL; mg/30mL; mg/30mL |
|---|
| Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC] |
|---|