NDC Code | 55315-006-33 |
Package Description | 245.5 mL in 1 BOTTLE (55315-006-33) |
Product NDC | 55315-006 |
Product Type Name | HUMAN OTC DRUG |
Proprietary Name | Daytime Severe Cold And Cough |
Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr And Phenylephrine Hcl |
Dosage Form | SYRUP |
Usage | ORAL |
Start Marketing Date | 20160609 |
End Marketing Date | 20220701 |
Marketing Category Name | OTC MONOGRAPH FINAL |
Application Number | part341 |
Manufacturer | Fred's, Inc. |
Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
Strength | 650; 20; 10 |
Strength Unit | mg/30mL; mg/30mL; mg/30mL |
Pharmacy Classes | Adrenergic alpha1-Agonists [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] |