| NDC Code | 28595-250-16 |
|---|
| Package Description | 473 mL in 1 BOTTLE (28595-250-16) |
|---|
| Product NDC | 28595-250 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Histex Ac |
|---|
| Non-Proprietary Name | Codeine Phosphate, Phenylephrine Hydrochloride, And Triprolidine Hydrochloride |
|---|
| Dosage Form | SYRUP |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20150812 |
|---|
| Marketing Category Name | OTC MONOGRAPH FINAL |
|---|
| Application Number | part341 |
|---|
| Manufacturer | Allegis Pharmaceuticals, LLC |
|---|
| Substance Name | CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE |
|---|
| Strength | 10; 10; 2.5 |
|---|
| Strength Unit | mg/5mL; mg/5mL; mg/5mL |
|---|
| Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], Full Opioid Agonists [MoA], Opioid Agonist [EPC], alpha-1 Adrenergic Agonist [EPC] |
|---|
| DEA Schedule | CV |
|---|