| NDC Code | 83393-777-01 |
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| Package Description | 30 mL in 1 BOTTLE, PLASTIC (83393-777-01) |
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| Product NDC | 83393-777 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Nighttime Cold And Flu |
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| Non-Proprietary Name | Acetaminophen, Dextromethorphan, Doxylamine Succinate |
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| Dosage Form | LIQUID |
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| Usage | ORAL |
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| Start Marketing Date | 20230411 |
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| Marketing Category Name | OTC MONOGRAPH DRUG |
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| Application Number | M010 |
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| Manufacturer | Laboratorios Sanfer, S.A. de C.V. |
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| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE |
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| Strength | 650; 30; 12.5 |
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| Strength Unit | mg/30mL; mg/30mL; mg/30mL |
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| Pharmacy Classes | Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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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