| NDC Code | 83057-0001-6 |
|---|
| Package Description | 1 BOTTLE in 1 CARTON (83057-0001-6) / 180 mL in 1 BOTTLE |
|---|
| Product NDC | 83057-0001 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Novalgina |
|---|
| Proprietary Name Suffix | Children Cough And Cold |
|---|
| Non-Proprietary Name | Acetaminofen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl |
|---|
| Dosage Form | LIQUID |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20221101 |
|---|
| Marketing Category Name | OTC MONOGRAPH FINAL |
|---|
| Application Number | part341 |
|---|
| Manufacturer | HBC Pharma, LLC |
|---|
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
|---|
| Strength | 250; 13.33; 200; 5 |
|---|
| Strength Unit | mg/10mL; mg/10mL; mg/10mL; mg/10mL |
|---|
| 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] |
|---|