| NDC Code | 58552-317-02 |
| Package Description | 12 BLISTER PACK in 1 CARTON (58552-317-02) > 2 TABLET, FILM COATED in 1 BLISTER PACK |
| Product NDC | 58552-317 |
| Product Type Name | HUMAN OTC DRUG |
| Proprietary Name | Giltuss Total Release |
| Non-Proprietary Name | Guaifenesin, Dextromethorphan Hbr, And Phenylephrine Hcl |
| Dosage Form | TABLET, FILM COATED |
| Usage | ORAL |
| Start Marketing Date | 20091019 |
| Marketing Category Name | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Manufacturer | Gil Pharmaceutical Corp |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Strength | 28; 388; 10 |
| Strength Unit | mg/1; mg/1; mg/1 |
| Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |