| NDC Code | 58593-830-06 |
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| Package Description | 1 BOTTLE in 1 CARTON (58593-830-06) / 180 mL in 1 BOTTLE |
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| Product NDC | 58593-830 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Rompe Pecho |
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| Proprietary Name Suffix | Nighttime |
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| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl |
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| Dosage Form | LIQUID |
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| Usage | ORAL |
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| Start Marketing Date | 20190901 |
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| Marketing Category Name | OTC MONOGRAPH DRUG |
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| Application Number | M012 |
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| Manufacturer | EFFICIENT LABORATORIES INC |
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| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE |
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| Strength | 650; 20; 12.5; 10 |
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| Strength Unit | mg/30mL; mg/30mL; mg/30mL; mg/30mL |
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| Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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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