NDC Code | 50066-301-04 |
Package Description | 1 BOTTLE, PLASTIC in 1 CARTON (50066-301-04) / 118 mL in 1 BOTTLE, PLASTIC |
Product NDC | 50066-301 |
Product Type Name | HUMAN OTC DRUG |
Proprietary Name | Tukol Honey Children Cough And Congestion |
Non-Proprietary Name | Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride |
Dosage Form | SYRUP |
Usage | ORAL |
Start Marketing Date | 20200209 |
Marketing Category Name | OTC MONOGRAPH DRUG |
Application Number | M012 |
Manufacturer | Genomma Lab USA |
Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
Strength | 5; 50; 2.5 |
Strength Unit | mg/2.5mL; mg/2.5mL; mg/2.5mL |
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] |