| NDC Code | 69367-272-16 |
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| Package Description | 473 mL in 1 BOTTLE (69367-272-16) |
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| Product NDC | 69367-272 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Codeine-guaifenesin |
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| Non-Proprietary Name | Codeine Phosphate And Guaifenesin |
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| Dosage Form | SOLUTION |
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| Usage | ORAL |
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| Start Marketing Date | 20200715 |
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| Marketing Category Name | OTC MONOGRAPH DRUG |
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| Application Number | M012 |
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| Manufacturer | Westminster Pharmaceuticals, LLC |
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| Substance Name | CODEINE PHOSPHATE; GUAIFENESIN |
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| Strength | 10; 100 |
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| Strength Unit | mg/5mL; mg/5mL |
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| Pharmacy Classes | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Full Opioid Agonists [MoA], Increased Respiratory Secretions [PE], Opioid Agonist [EPC] |
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| DEA Schedule | CV |
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