| NDC Code | 69365-003-01 |
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| Package Description | 1 BLISTER PACK in 1 CARTON (69365-003-01) / 1 CAPSULE in 1 BLISTER PACK / 10 CAPSULE, LIQUID FILLED in 1 CAPSULE |
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| Product NDC | 69365-003 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Facol Cold And Flu Night |
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| Non-Proprietary Name | Acetaminophen, Guaifenesin, Phenylephrine Hcl, Dextromethorphan Hbr, Diphenhydramine Hcl |
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| Dosage Form | CAPSULE, LIQUID FILLED |
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| Usage | ORAL |
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| Start Marketing Date | 20150801 |
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| Marketing Category Name | OTC MONOGRAPH DRUG |
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| Application Number | M012 |
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| Manufacturer | JW HOLDINGS |
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| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DIPHENHYDRAMINE HYDROCHLORIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
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| Strength | 200; 8; 18.75; 35; 5 |
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| Strength Unit | mg/1; 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], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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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