Label: MYLANTA MAXIMUM STRENGTH CLASSIC FLAVOR ANTACID AND ANTI GAS- aluminum hydroxide, magnesium hydroxide, and dimethicone liquid

  • NDC Code(s): 29485-8127-4
  • Packager: Lil' Drug Store Products, Inc.
  • 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 July 19, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 10 mL dose)Purposes
    Aluminum hydroxide (equivalent to dried gel, USP), 800 mgAntacid
    Magnesium hydroxide, 800 mgAntacid
    Simethicone, 80 mgAnti-gas
  • Use

    relieves:

    • heartburn
    • acid indigestion
    • sour stomach
    • upset stomach due to these symptoms
    • pressure and bloating commonly referred to as gas
    • overindulgence in food & drink
  • Warnings

    Ask a doctor before use if you have

    • kidney disease or magnesium restricted diet.

    Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

    Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

  • Directions

    • adults and children 12 years and over: Take one 10 mL dose as needed or as directed by a doctor
    • do not take more than 60 mL (6 doses) in any 24-hour period
    • do not use the maximum dosage for more than 2 weeks
    • children under 12 years: ask a doctor
  • Other information

    • each 10 mL dose contains:
      magnesium 340 mg; sodium 7 mg
    • store between 20-25°C (68-77°F), do not freeze
  • Inactive Ingredients

    benzyl alcohol, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, purified water, sodium carbonate, sorbitol, sucralose, xanthan gum

  • Questions or comments?

    1-844-695-6624

  • SPL UNCLASSIFIED SECTION

    Repackaged and distributed by Convenience Valet ®
    Glendale Heights, IL 60139

  • PRINCIPAL DISPLAY PANEL - 10 mL Pouch Carton

    Mylanta ®

    MAXIMUM
    STRENGTH

    STARTS
    TO WORK
    ON CONTACT!

    • Tough on Heartburn
    • Soothing Fast Relief

    SMOOTH
    CREAMY TASTE

    Classic
    Flavor

    ANTACID
    +
    ANTI-GAS

    Alcohol 0.2%

    4 Single Dose
    Pouches
    0.3 FL OZ (10 mL)
    Each

    PRINCIPAL DISPLAY PANEL - 10 mL Pouch Carton
  • INGREDIENTS AND APPEARANCE
    MYLANTA MAXIMUM STRENGTH CLASSIC FLAVOR ANTACID AND ANTI GAS 
    aluminum hydroxide, magnesium hydroxide, and dimethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-8127
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE800 mg  in 10 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE800 mg  in 10 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-8127-44 in 1 CARTON03/04/201903/31/2026
    110 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00111/10/201603/31/2026
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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