| NDC Code | 63102-104-16 |
|---|
| Package Description | 474 mL in 1 BOTTLE, PLASTIC (63102-104-16) |
|---|
| Product NDC | 63102-104 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Actinel Dm |
|---|
| Non-Proprietary Name | Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl |
|---|
| Dosage Form | SOLUTION |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20190520 |
|---|
| Marketing Category Name | OTC MONOGRAPH FINAL |
|---|
| Application Number | part341 |
|---|
| Manufacturer | Actipharma, Inc |
|---|
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
|---|
| Strength | 20; 400; 10 |
|---|
| Strength Unit | mg/5mL; mg/5mL; mg/5mL |
|---|
| Pharmacy Classes | Adrenergic alpha1-Agonists [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] |
|---|