| 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] |