Label: ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE- aluminum hydroxide, magnesium carbonate tablet, chewable

  • NDC Code(s): 76457-001-00
  • Packager: Simpex Pharma Pvt. Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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  • Drug Facts

  • Active ingredient (in each tablet)

    Aluminum hydroxide, 160 mg

    Magnesium carbonate, 105 mg

    Purpose

    Antacid

  • Uses

    Relieves acid indigestion leading to

    • stomach upset
    • heart burn
  • Warnings

    Ask a doctor before use if you have

    • kidney disease
    • a magnesium or sodium-restricted diet

    Ask a doctor or pharmacist before use if you are

    • now taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this product

    do not take more than 16 tablets in a 24-hour period or use the maximum dosage for more than 2 weeks

    Keep out of reach of children.

  • Directions

    • chew 2 to 4 tablets four times a day or as directed by a doctor
    • take after meals and at bedtime or as needed
    • for best results follow by a half glass of water or other liquid
    • do not swallow whole
  • Other information

    • each tablet contains: magnesium 50 mg and sodium 32 mg
    • store at 20°-25°C
  • Inactive ingredients

    alginic acid, calcium stearate, color red iron oxide, flavor (mint), maize starch, magnesium oxide, mannitol, sodium bicarbonate, sucrose

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE  
    aluminum hydroxide, magnesium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76457-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE160 mg
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE105 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALGINIC ACID (UNII: 8C3Z4148WZ)  
    CALCIUM STEARATE (UNII: 776XM7047L)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    MANNITOL (UNII: 3OWL53L36A)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colororange (orange) Score2 pieces
    ShapeROUND (round biconvex film-coated tablet plain from both sides) Size13mm
    FlavorImprint Code ;
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76457-001-001 in 1 CARTON02/09/2018
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00102/09/2018
    Labeler - Simpex Pharma Pvt. Ltd (916758275)
    Registrant - Simpex Pharma Pvt. Ltd (916758275)
    Establishment
    NameAddressID/FEIBusiness Operations
    Simpex Pharma Pvt. Ltd916758275manufacture(76457-001)
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