Product ID | 66576-335_e1502b49-a051-2c07-e053-2995a90a3151 |
NDC | 66576-335 |
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 | Syntho Pharmaceuticals, Inc. |
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 |