| NDC Code | 83057-0001-6 |
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| Package Description | 1 BOTTLE in 1 CARTON (83057-0001-6) / 180 mL in 1 BOTTLE |
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| Product NDC | 83057-0001 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Novalgina |
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| Proprietary Name Suffix | Children Cough And Cold |
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| Non-Proprietary Name | Acetaminofen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl |
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| Dosage Form | LIQUID |
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| Usage | ORAL |
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| Start Marketing Date | 20221101 |
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| Marketing Category Name | OTC MONOGRAPH DRUG |
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| Application Number | M012 |
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| Manufacturer | HBC Pharma, LLC |
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| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
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| Strength | 250; 13.33; 200; 5 |
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| Strength Unit | mg/10mL; mg/10mL; mg/10mL; mg/10mL |
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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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