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
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 21, 2018

If you are a consumer or patient please visit this version.

  • 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 finalpart33102/09/2018
    Labeler - Simpex Pharma Pvt. Ltd (916758275)
    Registrant - Simpex Pharma Pvt. Ltd (916758275)
    Establishment
    NameAddressID/FEIBusiness Operations
    Simpex Pharma Pvt. Ltd916758275manufacture(76457-001)