| NDC Code | 53002-3191-1 |
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| Package Description | 118 mL in 1 BOTTLE (53002-3191-1) |
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| Product NDC | 53002-3191 |
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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 | 20061001 |
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| Marketing Category Name | OTC MONOGRAPH FINAL |
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| Application Number | part341 |
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| Manufacturer | RPK 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 | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
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| DEA Schedule | CV |
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