| NDC Code | 0067-6095-01 |
|---|
| Package Description | 8 POUCH in 1 CARTON (0067-6095-01) / 1 POWDER, FOR SOLUTION in 1 POUCH (0067-6095-02) |
|---|
| Product NDC | 0067-6095 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Theraflu |
|---|
| Proprietary Name Suffix | Powerpods Nighttime Severe Cold |
|---|
| Non-Proprietary Name | Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl |
|---|
| Dosage Form | POWDER, FOR SOLUTION |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20180728 |
|---|
| 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/1; mg/1; mg/1 |
|---|
| Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC] |
|---|