| NDC Code | 55758-311-06 |
|---|
| Package Description | 1 BOTTLE, WITH APPLICATOR in 1 BOX (55758-311-06) / 1 LIQUID in 1 BOTTLE, WITH APPLICATOR |
|---|
| Product NDC | 55758-311 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Sanatos X |
|---|
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr,guaifenesin, Phenylephrine Hci |
|---|
| Dosage Form | LIQUID |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20181203 |
|---|
| Marketing Category Name | OTC MONOGRAPH DRUG |
|---|
| Application Number | M013 |
|---|
| Manufacturer | Pharmadel LLC |
|---|
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
|---|
| Strength | 650; 20; 400; 10 |
|---|
| Strength Unit | mg/1; mg/1; mg/1; mg/1 |
|---|
| 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] |
|---|