| NDC Code | 57237-316-31 |
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| Package Description | 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-316-31) / 30 mL in 1 CUP, UNIT-DOSE (57237-316-03) |
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| Product NDC | 57237-316 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Aluminum Hydroxide, Magnesium Hydroxide And Simethicone |
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| Non-Proprietary Name | Aluminum Hydroxide, Magnesium Hydroxide, And Simethicone |
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| Dosage Form | SUSPENSION |
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| Usage | ORAL |
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| Start Marketing Date | 20230815 |
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| Marketing Category Name | OTC MONOGRAPH DRUG |
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| Application Number | M001.15 |
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| Manufacturer | Rising Pharma Holdings, Inc. |
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| Substance Name | ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE |
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| Strength | 1200; 120; 1200 |
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| Strength Unit | mg/30mL; mg/30mL; mg/30mL |
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| Pharmacy Classes | Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
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