| NDC Code | 50332-0141-4 |
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| Package Description | 40 PACKET in 1 BOX (50332-0141-4) / 2 TABLET, FILM COATED in 1 PACKET |
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| Product NDC | 50332-0141 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Cetafen Cough And Cold |
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| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl , Guaifenesin, , |
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| Dosage Form | TABLET, FILM COATED |
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| Usage | ORAL |
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| Start Marketing Date | 20230109 |
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| Marketing Category Name | OTC MONOGRAPH FINAL |
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| Application Number | part341 |
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| Manufacturer | HART Health |
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| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
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| Strength | 325; 10; 100; 5 |
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| Strength Unit | mg/1; mg/1; mg/1; mg/1 |
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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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