NDC Code | 68210-4194-1 |
Package Description | 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68210-4194-1) |
Product NDC | 68210-4194 |
Product Type Name | HUMAN OTC DRUG |
Proprietary Name | Maximum Strength Severe Congestion Relief |
Non-Proprietary Name | Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride |
Dosage Form | CAPSULE, LIQUID FILLED |
Usage | ORAL |
Start Marketing Date | 20211228 |
Marketing Category Name | OTC MONOGRAPH DRUG |
Application Number | M012 |
Manufacturer | Spirit Pharmaceuticals LLC |
Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
Strength | 325; 10; 200; 5 |
Strength Unit | mg/1; mg/1; mg/1; mg/1 |
Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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] |