| NDC Code | 35916-0184-2 |
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| Package Description | 3000 CAPSULE, LIQUID FILLED in 1 POUCH (35916-0184-2) |
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| Product NDC | 35916-0184 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Acetaminophen, Dextromethorphan Hbr ,guaifenesin |
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| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr ,guaifenesin |
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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 Pvt Ltd |
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| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
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| Strength | 325; 10; 200 |
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| Strength Unit | mg/1; mg/1; mg/1 |
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| Pharmacy Classes | 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] |
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