| NDC Code | 68788-8361-1 |
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| Package Description | 118 mL in 1 BOTTLE (68788-8361-1) |
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| Product NDC | 68788-8361 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Guaifenesin And Codeine Phosphate |
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| Non-Proprietary Name | Guaifenesin And Codeine Phosphate |
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| Dosage Form | SOLUTION |
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| Usage | ORAL |
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| Start Marketing Date | 20230201 |
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| Marketing Category Name | OTC MONOGRAPH DRUG |
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| Application Number | MO12 |
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| Manufacturer | Preferred Pharmaceuticals Inc. |
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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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