| NDC Code | 69729-784-06 |
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| Package Description | 1 BOTTLE, PLASTIC in 1 CARTON (69729-784-06) / 177 mL in 1 BOTTLE, PLASTIC |
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| Product NDC | 69729-784 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Rompe Tos X Children |
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| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl |
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| Dosage Form | SYRUP |
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| Usage | ORAL |
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| Start Marketing Date | 20230918 |
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| Marketing Category Name | OTC MONOGRAPH FINAL |
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| Application Number | part341 |
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| Manufacturer | OPMX LLC |
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| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
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| Strength | 250; 13.33; 200; 5 |
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| Strength Unit | mg/10mL; mg/10mL; mg/10mL; mg/10mL |
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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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