| NDC Code | 0031-8765-16 |
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| Package Description | 2 BLISTER PACK in 1 CARTON (0031-8765-16) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
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| Product NDC | 0031-8765 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Robitussin Maximum Strength 12 Hour Cough And Mucus Relief |
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| Non-Proprietary Name | Dextromethorphan Hydrobromide, Guaifenesin |
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| Dosage Form | TABLET, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20190614 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA207602 |
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| Manufacturer | Haleon US Holdings LLC |
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| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
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| Strength | 60; 1200 |
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| Strength Unit | 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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