| NDC Code | 70000-0183-2 |
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| Package Description | 237 mL in 1 BOTTLE (70000-0183-2) |
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| Product NDC | 70000-0183 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Leader Nighttime Cold And Flu |
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| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate |
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| Dosage Form | SOLUTION |
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| Usage | ORAL |
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| Start Marketing Date | 20161116 |
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| Marketing Category Name | OTC MONOGRAPH FINAL |
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| Application Number | part341 |
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| Manufacturer | Cardinal Health 110, LLC. dba Leader |
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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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