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] |