| NDC Code | 36800-594-40 |
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| Package Description | 355 mL in 1 BOTTLE (36800-594-40) |
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| Product NDC | 36800-594 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Topcare Nite Time Cold And Flu |
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| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride |
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| Dosage Form | SOLUTION |
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| Usage | ORAL |
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| Start Marketing Date | 20190801 |
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| Marketing Category Name | OTC MONOGRAPH FINAL |
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| Application Number | part341 |
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| Manufacturer | Topco Associates LLC |
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| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE |
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| Strength | 650; 20; 12.5; 10 |
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| Strength Unit | mg/30mL; mg/30mL; mg/30mL; mg/30mL |
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| Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC] |
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