| NDC Code | 49580-0415-8 |
|---|
| Package Description | 237 mL in 1 BOTTLE, PLASTIC (49580-0415-8) |
|---|
| Product NDC | 49580-0415 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Severe Cold And Flu Relief |
|---|
| Proprietary Name Suffix | Daytime |
|---|
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride |
|---|
| Dosage Form | LIQUID |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20210326 |
|---|
| Marketing Category Name | OTC MONOGRAPH DRUG |
|---|
| Application Number | M012 |
|---|
| Manufacturer | P & L Development, LLC |
|---|
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
|---|
| Strength | 325; 10; 200; 5 |
|---|
| Strength Unit | mg/15mL; mg/15mL; mg/15mL; mg/15mL |
|---|
| 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] |
|---|