| NDC Code | 0031-8765-08 |
|---|
| Package Description | 1 BLISTER PACK in 1 CARTON (0031-8765-08) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
|---|
| Product NDC | 0031-8765 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Robitussin Maximum Strength 12 Hour Cough And Mucus Relief |
|---|
| Non-Proprietary Name | Dextromethorphan Hydrobromide, Guaifenesin |
|---|
| Dosage Form | TABLET, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20190614 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA207602 |
|---|
| Manufacturer | Haleon US Holdings LLC |
|---|
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
|---|
| Strength | 60; 1200 |
|---|
| 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] |
|---|