| NDC Code | 57631-013-10 |
|---|
| Package Description | 26500 TABLET in 1 BOX (57631-013-10) |
|---|
| Product NDC | 57631-013 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Guaifenesin And Dextromethorphan Hydrobromide |
|---|
| Non-Proprietary Name | Guaifenesin And Dextromethorphan Hydrobromide |
|---|
| Dosage Form | TABLET |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20210113 |
|---|
| Marketing Category Name | OTC MONOGRAPH DRUG |
|---|
| Application Number | M012 |
|---|
| Manufacturer | InvaTech Pharma Solutions LLC |
|---|
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
|---|
| Strength | 20; 400 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | 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] |
|---|