| NDC Code | 55758-520-08 |
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| Package Description | 1 BOTTLE, PLASTIC in 1 CARTON (55758-520-08) / 237 mL in 1 BOTTLE, PLASTIC |
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| Product NDC | 55758-520 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Broncolito |
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| Proprietary Name Suffix | Children |
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| Non-Proprietary Name | Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride |
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| Dosage Form | SYRUP |
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| Usage | ORAL |
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| Start Marketing Date | 20260701 |
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| Marketing Category Name | OTC MONOGRAPH DRUG |
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| Application Number | M012 |
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| Manufacturer | Pharmadel LLC |
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| Substance Name | GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE |
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| Strength | 5; 50; 2.5 |
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| Strength Unit | mg/2.5mL; mg/2.5mL; mg/2.5mL |
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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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