| NDC Code | 50580-299-01 |
|---|
| Package Description | 1 BOTTLE in 1 CARTON (50580-299-01) / 120 mL in 1 BOTTLE |
|---|
| Product NDC | 50580-299 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Childrens Tylenol |
|---|
| Proprietary Name Suffix | Cold Plus Flu |
|---|
| Non-Proprietary Name | Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride |
|---|
| 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; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
|---|
| Strength | 160; 1; 5; 2.5 |
|---|
| Strength Unit | mg/5mL; mg/5mL; mg/5mL; mg/5mL |
|---|
| Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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] |
|---|