| Product ID | 58552-335_e14d6c89-6648-1888-e053-2995a90ab32a |
| NDC | 58552-335 |
| Product Type | Human Otc Drug |
| Proprietary Name | Giltuss TR |
| Generic Name | Guaifenesin,dextromethorphan Hbr,phenylephrine Hcl |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2022-01-07 |
| Marketing Category | OTC MONOGRAPH FINAL / |
| Application Number | part341 |
| Labeler Name | Gil Pharmaceutical Corp |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Active Ingredient Strength | 29 mg/1; mg/1; mg/1 |
| Pharm Classes | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |