| NDC Code | 36800-948-40 |
|---|
| Package Description | 355 mL in 1 BOTTLE (36800-948-40) |
|---|
| Product NDC | 36800-948 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Topcare Day Time Cold And Flu |
|---|
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride |
|---|
| Dosage Form | SOLUTION |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20190801 |
|---|
| Marketing Category Name | OTC MONOGRAPH FINAL |
|---|
| Application Number | part341 |
|---|
| Manufacturer | Topco Associates LLC |
|---|
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
|---|
| Strength | 650; 20; 400; 10 |
|---|
| Strength Unit | mg/30mL; mg/30mL; mg/30mL; mg/30mL |
|---|
| Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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] |
|---|