| NDC Code | 76864-208-01 |
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| Package Description | 1 BOTTLE, PLASTIC in 1 CARTON (76864-208-01) / 120 mL in 1 BOTTLE, PLASTIC |
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| Product NDC | 76864-208 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Baczol Cold Medicine |
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| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr, Chlorpheniramine Maleate, Phenylephrine Hcl |
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| Dosage Form | SYRUP |
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| Usage | ORAL |
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| Start Marketing Date | 20200525 |
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| Marketing Category Name | OTC MONOGRAPH FINAL |
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| Application Number | part341 |
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| Manufacturer | Procaps S.A. de C.V. |
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| Substance Name | ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
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| Strength | 250; 4; 10; 10 |
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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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