| NDC Code | 50804-503-08 |
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| Package Description | 2 BLISTER PACK in 1 CARTON (50804-503-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK |
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| Product NDC | 50804-503 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Cold And Flu |
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| Proprietary Name Suffix | Severe |
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| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl |
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| Dosage Form | TABLET, FILM COATED |
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| Usage | ORAL |
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| Start Marketing Date | 20200609 |
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| Marketing Category Name | OTC MONOGRAPH DRUG |
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| Application Number | M012 |
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| Manufacturer | Geiss, Destin & Dunn Inc. |
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| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
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| Strength | 325; 10; 200; 5 |
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| Strength Unit | mg/1; mg/1; mg/1; mg/1 |
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| Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC] |
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