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    NDC 57237-0316-31 Aluminum Hydroxide, Magnesium Hydroxide and Simethicone 1200; 120; 1200 mg/30mL; mg/30mL; mg/30mL Details

    Aluminum Hydroxide, Magnesium Hydroxide and Simethicone 1200; 120; 1200 mg/30mL; mg/30mL; mg/30mL

    Aluminum Hydroxide, Magnesium Hydroxide and Simethicone is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Rising Pharma Holdings, Inc.. The primary component is ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE.

    Product Information

    NDC 57237-0316
    Product ID 57237-316_ab66959e-fe45-468f-aebd-87087d1f6738
    Associated GPIs
    GCN Sequence Number 002701
    GCN Sequence Number Description mag hydrox/aluminum hyd/simeth ORAL SUSP 200-200-20 ORAL
    HIC3 D4B
    HIC3 Description ANTACIDS
    GCN 63910
    HICL Sequence Number 001168
    HICL Sequence Number Description MAGNESIUM HYDROXIDE/ALUMINUM HYDROXIDE/SIMETHICONE
    Brand/Generic Generic
    Proprietary Name Aluminum Hydroxide, Magnesium Hydroxide and Simethicone
    Proprietary Name Suffix n/a
    Non-Proprietary Name Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone
    Product Type HUMAN OTC DRUG
    Dosage Form SUSPENSION
    Route ORAL
    Active Ingredient Strength 1200; 120; 1200
    Active Ingredient Units mg/30mL; mg/30mL; mg/30mL
    Substance Name ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE
    Labeler Name Rising Pharma Holdings, Inc.
    Pharmaceutical Class 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
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH FINAL
    Application Number part331
    Listing Certified Through 2024-12-31

    Package

    NDC 57237-0316-31 (57237031631)

    NDC Package Code 57237-316-31
    Billing NDC 57237031631
    Package 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-316-31) / 30 mL in 1 CUP, UNIT-DOSE (57237-316-03)
    Marketing Start Date 2023-08-15
    NDC Exclude Flag N
    Pricing Information N/A