NDC Code | 50580-194-01 |
Package Description | 1 BOTTLE in 1 CARTON (50580-194-01) / 120 mL in 1 BOTTLE |
Product NDC | 50580-194 |
Product Type Name | HUMAN OTC DRUG |
Proprietary Name | Childrens Tylenol |
Proprietary Name Suffix | Cold Plus Cough Plus Sore Throat |
Non-Proprietary Name | Acetaminophen And Dextromethorphan Hydrobromide |
Dosage Form | SUSPENSION |
Usage | ORAL |
Start Marketing Date | 20170626 |
Marketing Category Name | OTC MONOGRAPH DRUG |
Application Number | M012 |
Manufacturer | Kenvue Brands LLC |
Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE |
Strength | 160; 5 |
Strength Unit | mg/5mL; mg/5mL |
Pharmacy Classes | Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |