| NDC Code | 71309-110-50 |
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| Package Description | 50 POUCH in 1 BOX (71309-110-50) > 2 TABLET, COATED in 1 POUCH |
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| Product NDC | 71309-110 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Sleep-ez Nighttime Sleep Aid |
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| Non-Proprietary Name | Diphenhydramine Hcl 25 Mg |
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| Dosage Form | TABLET, COATED |
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| Usage | ORAL |
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| Start Marketing Date | 20170601 |
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| Marketing Category Name | OTC MONOGRAPH FINAL |
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| Application Number | part341 |
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| Manufacturer | Safrel Pharmaceuticals, LLC. |
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| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE |
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| Strength | 25 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
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