| NDC Code | 0067-0104-08 |
|---|
| Package Description | 245.5 mL in 1 BOTTLE (0067-0104-08) |
|---|
| Product NDC | 0067-0104 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Theraflu |
|---|
| Proprietary Name Suffix | Severe Cold Relief Chest Congestion Daytime |
|---|
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr, Guaifenesin |
|---|
| Dosage Form | SYRUP |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20231201 |
|---|
| Marketing Category Name | OTC MONOGRAPH DRUG |
|---|
| Application Number | M012 |
|---|
| Manufacturer | Haleon US Holdings LLC |
|---|
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
|---|
| Strength | 650; 20; 400 |
|---|
| Strength Unit | mg/30mL; mg/30mL; mg/30mL |
|---|
| Pharmacy Classes | 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] |
|---|