| NDC Code | 0904-7512-70 |
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| Package Description | 10 TRAY in 1 CASE (0904-7512-70) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7512-41) |
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| Product NDC | 0904-7512 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Guaifenesin And Dextromethorphan |
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| Non-Proprietary Name | Guaifenesin And Dextromethorphan |
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| Dosage Form | SYRUP |
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| Usage | ORAL |
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| Start Marketing Date | 20250210 |
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| Marketing Category Name | OTC MONOGRAPH DRUG |
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| Application Number | M012 |
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| Manufacturer | Major Pharmaceuticals |
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| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
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| Strength | 10; 100 |
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| Strength Unit | mg/5mL; mg/5mL |
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| Pharmacy Classes | 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] |
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