| NDC Code | 50066-315-04 |
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| Package Description | 1 BOTTLE, PLASTIC in 1 CARTON (50066-315-04) / 118 mL in 1 BOTTLE, PLASTIC |
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| Product NDC | 50066-315 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Tukol Childrens Cold And Flu |
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| Non-Proprietary Name | Acetaminophen, 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 | 20230117 |
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| Marketing Category Name | OTC MONOGRAPH FINAL |
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| Application Number | part341 |
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| Manufacturer | Genomma Lab USA |
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| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
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| Strength | 32.5; 1; 20; .5 |
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| Strength Unit | mg/mL; mg/mL; mg/mL; mg/mL |
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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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