| NDC Code | 50580-456-01 |
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| Package Description | 1 BOTTLE in 1 CARTON (50580-456-01) / 120 mL in 1 BOTTLE |
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| Product NDC | 50580-456 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Childrens Tylenol |
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| Proprietary Name Suffix | Cold Plus Flu |
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| Non-Proprietary Name | Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride |
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| Dosage Form | SUSPENSION |
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| Usage | ORAL |
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| Start Marketing Date | 20170626 |
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| Marketing Category Name | OTC MONOGRAPH DRUG |
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| Application Number | M012 |
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| Manufacturer | Kenvue Brands LLC |
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| Substance Name | ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
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| Strength | 160; 1; 5; 2.5 |
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| Strength Unit | mg/5mL; mg/5mL; mg/5mL; mg/5mL |
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| Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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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