| NDC Code | 80513-301-50 |
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| Package Description | 50 CAPSULE, GELATIN COATED in 1 BOTTLE (80513-301-50) |
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| Product NDC | 80513-301 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Daytime Cold And Flu Relief Softgels |
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| Proprietary Name Suffix | Non-drowsy |
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| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr, Phenylephrine |
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| Dosage Form | CAPSULE, GELATIN COATED |
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| Usage | ORAL |
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| Start Marketing Date | 20230424 |
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| Marketing Category Name | OTC MONOGRAPH FINAL |
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| Application Number | part341 |
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| Manufacturer | Advanced Rx LLC |
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| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DIPHENHYDRAMINE HYDROCHLORIDE |
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| Strength | 325; 10; 5 |
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| Strength Unit | mg/1; mg/1; mg/1 |
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| Pharmacy Classes | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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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