| NDC Code | 0067-0111-01 |
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| Package Description | 20 TABLET, CHEWABLE in 1 BOTTLE (0067-0111-01) |
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| Product NDC | 0067-0111 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Theraflu |
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| Proprietary Name Suffix | Severe Cold Relief Soft Chews |
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| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr |
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| Dosage Form | TABLET, CHEWABLE |
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| Usage | ORAL |
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| Start Marketing Date | 20240619 |
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| Marketing Category Name | OTC MONOGRAPH DRUG |
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| Application Number | M012 |
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| Manufacturer | Haleon US Holdings LLC |
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| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE |
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| Strength | 325; 10 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | 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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