NDC Code | 68210-4210-1 |
Package Description | 1 BLISTER PACK in 1 CARTON (68210-4210-1) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
Product NDC | 68210-4210 |
Product Type Name | HUMAN OTC DRUG |
Proprietary Name | Maximum Strength Nighttime Sever Cold And Flu |
Non-Proprietary Name | Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride |
Dosage Form | CAPSULE, LIQUID FILLED |
Usage | ORAL |
Start Marketing Date | 20220819 |
Marketing Category Name | OTC MONOGRAPH FINAL |
Application Number | part341 |
Manufacturer | Spirit Pharmaceuticals LLC |
Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE |
Strength | 325; 10; 200; 5 |
Strength Unit | mg/1; mg/1; mg/1; mg/1 |
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] |