| NDC Code | 35916-0166-1 |
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| Package Description | 2 BLISTER PACK in 1 CARTON (35916-0166-1) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
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| Product NDC | 35916-0166 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Acetaminophen, Guaifenesin, Phenylephrine Hcl And Dextromethorphan Hbr |
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| Non-Proprietary Name | Acetaminophen, Guaifenesin, Phenylephrine Hcl And Dextromethorphan Hbr |
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| Dosage Form | CAPSULE, LIQUID FILLED |
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| Usage | ORAL |
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| Start Marketing Date | 20241029 |
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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; PHENYLEPHRINE HYDROCHLORIDE |
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| Strength | 325; 10; 200; 5 |
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| Strength Unit | mg/1; mg/1; mg/1; mg/1 |
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| Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC] |
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