| NDC Code | 0067-6803-02 |
| Package Description | 6 PACKET in 1 CARTON (0067-6803-02) / 237 mL in 1 PACKET |
| Product NDC | 0067-6803 |
| Product Type Name | HUMAN OTC DRUG |
| Proprietary Name | Theraflu |
| Proprietary Name Suffix | Severe Cold Relief Nighttime |
| Non-Proprietary Name | Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl |
| Dosage Form | POWDER, FOR SOLUTION |
| Usage | ORAL |
| Start Marketing Date | 20230120 |
| Marketing Category Name | OTC MONOGRAPH DRUG |
| Application Number | M012 |
| Manufacturer | Haleon US Holdings LLC |
| Substance Name | ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Strength | 650; 25; 10 |
| Strength Unit | mg/237mL; mg/237mL; mg/237mL |
| Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC] |