| NDC Code | 68788-7921-1 |
|---|
| Package Description | 120 mL in 1 BOTTLE (68788-7921-1) |
|---|
| Product NDC | 68788-7921 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Codeine Guaifenesin |
|---|
| Non-Proprietary Name | Codeine Phosphate, Guaifenesin |
|---|
| Dosage Form | SOLUTION |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20210614 |
|---|
| Marketing Category Name | OTC MONOGRAPH FINAL |
|---|
| Application Number | part341 |
|---|
| Manufacturer | Preferred Pharmaceuticals Inc. |
|---|
| 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 |
|---|