| NDC Code | 48433-221-40 |
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| Package Description | 40 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (48433-221-40) / 5 mL in 1 CUP, UNIT-DOSE (48433-221-05) |
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| Product NDC | 48433-221 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Guaifenesin And Dextromethorphan Hbr |
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| Non-Proprietary Name | Guaifenesin And Dextromethorphan Hydrobromide |
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| Dosage Form | LIQUID |
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| Usage | ORAL |
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| Start Marketing Date | 20220201 |
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| End Marketing Date | 20231001 |
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| Marketing Category Name | OTC MONOGRAPH FINAL |
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| Application Number | part341 |
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| Manufacturer | Safecor Health, LLC |
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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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