| NDC Code | 50383-087-12 |
| Package Description | 10 TRAY in 1 CASE (50383-087-12) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-087-10) |
| Product NDC | 50383-087 |
| Product Type Name | HUMAN OTC DRUG |
| Proprietary Name | Guaiatussin Ac |
| Proprietary Name Suffix | Sugar Free |
| Non-Proprietary Name | Guaifenesin And Codeine Phosphate |
| Dosage Form | LIQUID |
| Usage | ORAL |
| Start Marketing Date | 20100908 |
| Marketing Category Name | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Manufacturer | Akorn Operating Company LLC |
| Substance Name | CODEINE PHOSPHATE; GUAIFENESIN |
| Strength | 10; 100 |
| Strength Unit | mg/5mL; mg/5mL |
| Pharmacy Classes | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Full Opioid Agonists [MoA], Increased Respiratory Secretions [PE], Opioid Agonist [EPC] |
| DEA Schedule | CV |