| NDC Code | 58593-830-06 |
| Package Description | 1 BOTTLE in 1 CARTON (58593-830-06) / 180 mL in 1 BOTTLE |
| Product NDC | 58593-830 |
| Product Type Name | HUMAN OTC DRUG |
| Proprietary Name | Rompe Pecho |
| Proprietary Name Suffix | Nighttime |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl |
| Dosage Form | LIQUID |
| Usage | ORAL |
| Start Marketing Date | 20190901 |
| End Marketing Date | 20261130 |
| Marketing Category Name | OTC MONOGRAPH DRUG |
| Application Number | M012 |
| Manufacturer | EFFICIENT LABORATORIES INC |
| 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 |
| Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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] |