| NDC Code | 55315-004-33 |
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| Package Description | 245.5 mL in 1 BOTTLE (55315-004-33) |
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| Product NDC | 55315-004 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Night Time Severe Cold And Cough |
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| Non-Proprietary Name | Acetaminophen, Diphenhydramine Hcl And Phenylephrine Hcl |
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| Dosage Form | SYRUP |
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| Usage | ORAL |
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| Start Marketing Date | 20160609 |
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| End Marketing Date | 20220801 |
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| Marketing Category Name | OTC MONOGRAPH FINAL |
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| Application Number | part341 |
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| Manufacturer | Fred's, Inc. |
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| Substance Name | ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE |
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| Strength | 650; 25; 10 |
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| Strength Unit | mg/30mL; mg/30mL; mg/30mL |
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| Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC] |
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