| NDC Code | 76281-519-24 |
|---|
| Package Description | 1 BOTTLE in 1 CARTON (76281-519-24) / 118 mL in 1 BOTTLE |
|---|
| Product NDC | 76281-519 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Childrens Cold Cough And Sore Throat Mixed Berry |
|---|
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl |
|---|
| Dosage Form | LIQUID |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20240130 |
|---|
| Marketing Category Name | OTC MONOGRAPH DRUG |
|---|
| Application Number | M012 |
|---|
| Manufacturer | AptaPharma Inc. |
|---|
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
|---|
| Strength | 325; 10; 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] |
|---|