| NDC Code | 70000-0453-1 |
| Package Description | 237 mL in 1 BOTTLE (70000-0453-1) |
| Product NDC | 70000-0453 |
| Product Type Name | HUMAN OTC DRUG |
| Proprietary Name | Leader Nighttime Sever Cold And Flu |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl |
| Dosage Form | SOLUTION |
| Usage | ORAL |
| Start Marketing Date | 20181227 |
| End Marketing Date | 20210831 |
| Marketing Category Name | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Manufacturer | Cardinal Health 110, LLC. dba Leader |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE |
| Strength | 650; 20; 12.5; 10 |
| Strength Unit | mg/30mL; mg/30mL; mg/30mL; mg/30mL |