| NDC Code | 58354-111-03 |
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| Package Description | 1 BLISTER PACK in 1 BOX (58354-111-03) > 10 CAPSULE in 1 BLISTER PACK (58354-111-02) > 320 mg in 1 CAPSULE (58354-111-01) |
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| Product NDC | 58354-111 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Colcol-s |
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| Non-Proprietary Name | Acetaminophen, Chlorpheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide Hydrate, Guaifenesin |
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| Dosage Form | CAPSULE |
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| Usage | ORAL |
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| Start Marketing Date | 20190221 |
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| Marketing Category Name | OTC MONOGRAPH FINAL |
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| Application Number | part341 |
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| Manufacturer | Cho-A Pharm.Co.,Ltd. |
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| Substance Name | ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE |
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| Strength | 200; 1.25; 7.5; 21; 15 |
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| Strength Unit | mg/320mg; mg/320mg; mg/320mg; mg/320mg; mg/320mg |
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| Pharmacy Classes | Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC] |
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