| NDC Code | 35916-0185-2 |
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| Package Description | 3000 CAPSULE, LIQUID FILLED in 1 POUCH (35916-0185-2) |
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| Product NDC | 35916-0185 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Acetaminophen, Dextromethorphan Hbr And Doxylamine Succinate |
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| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr And Doxylamine Succinate |
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| Dosage Form | CAPSULE, LIQUID FILLED |
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| Usage | ORAL |
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| Start Marketing Date | 20250517 |
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| Marketing Category Name | OTC MONOGRAPH DRUG |
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| Application Number | M012 |
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| Manufacturer | Softgel Healthcare Private Limited |
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| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE |
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| Strength | 325; 10; 6.25 |
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| Strength Unit | mg/1; mg/1; mg/1 |
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| Pharmacy Classes | Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
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