| NDC Code | 87078-972-32 |
|---|
| Package Description | 12 POUCH in 1 CARTON (87078-972-32) / 15 mL in 1 POUCH (87078-972-03) |
|---|
| Product NDC | 87078-972 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Onessip Adult Daytime Severe Cold And Flu |
|---|
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci |
|---|
| Dosage Form | SOLUTION |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20251215 |
|---|
| Marketing Category Name | OTC MONOGRAPH DRUG |
|---|
| Application Number | M012 |
|---|
| Manufacturer | MEDWISE LIFESCIENCES INC. |
|---|
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
|---|
| Strength | 650; 20; 400; 10 |
|---|
| 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] |
|---|