| NDC Code | 87078-331-16 |
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| Package Description | 16 POUCH in 1 CARTON (87078-331-16) / 10 mL in 1 POUCH (87078-331-01) |
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| Product NDC | 87078-331 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Onessip Day Time Kids Cold And Cough Plus Fever |
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| Non-Proprietary Name | Acetaminophen 325 Mg And Dextromethorphan Hbr 10 Mg Oral Liquid Day Time Kids |
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| Dosage Form | LIQUID |
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| Usage | ORAL |
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| Start Marketing Date | 20260515 |
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| Marketing Category Name | OTC MONOGRAPH DRUG |
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| Application Number | M012 |
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| Manufacturer | MEDWISE LIFESCIENCES INC. |
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| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE |
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| Strength | 325; 10 |
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| Strength Unit | mg/10mL; mg/10mL |
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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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