Label: MYLANTA MAXIMUM STRENGTH CLASSIC FLAVOR- antacid and anti gas aluminum hydroxide magnesium hydroxide and simethicone suspension

  • NDC Code(s): 62372-500-30
  • Packager: Infirst Healthcare 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 February 1, 2023

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  • Active ingredients (in each 2 tsp dose)

    Aluminum hydroxide
    (equivalent to dried gel, USP) 800 mg

    Magnesium hydroxide 800 mg

    Simethicone 80 mg

  • Purpose

    Antacid

    Antacid

    Anti-gas

  • Uses

    relieves:

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

    Ask a doctor before use if you have

    •
    kidney disease
    •
    a 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 at 1-800-222-1222.

  • Directions

    •
    shake well before use
    •
    adults and children 12 years and over:
    2 tsp – 4 tsp (1-2 doses) between meals, at bedtime or as directed by a doctor
    •
    do not take more than 12 tsp (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
    •
    tsp = teaspoon
  • Other information

    •
    each 2 tsp 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 comment?

    call 1-844-695-6624 toll free (English and Spanish)

  • Principal Display Panel

    MYLANTA®
    ANTACID
    +
    ANTI-GAS
    Alcohol 0.2%

    MAXIMUM STRENGTH

    WORKS ON CONTACT!

    •
    Tough on Heartburn
    •
    Gentle on Your Body

    SMOOTH CREAMY TASTE

    Classic
    FLAVOUR

    10 FL OZ (296 mL)

    78010-CLA-MYLLF

    The coating, acid-neutralizing power of Maximum Strength Mylanta® starts to work on contact.

    It helps soothe and relieve heartburn, acid indigestion, and bothersome gas symptoms so you can feel better fast. Tough on heartburn and gas, Mylanta works at the source of symptoms. It is gentle on your body with a great-tasting flavor, and can be used as directed every day.

    •
    Fast, multi-symptom relief
    •
    Coats and soothes
    •
    Paraben- free

    Active ingredients: Aluminum hydroxide, Magnesium hydroxide, Simethicone

    TAMPER-EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING


    78010-CLA-MYLLB

    Mylanta® is a registered trademark of McNeil Consumer Pharmaceuticals Co.

    infirst+
    HEALTHCARE

    Manufactured for:

    Infirst Healthcare Inc.
    Westport, CT 06880
    ©2021
    Infirst Healthcare Inc.
    Mylanta.com

    Mylanta Maximum Strength Classic Flavor, 10 FL OZ
  • INGREDIENTS AND APPEARANCE
    MYLANTA MAXIMUM STRENGTH CLASSIC FLAVOR 
    antacid and anti gas aluminum hydroxide magnesium hydroxide and simethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62372-500
    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) (MAGNESIUM CATION - UNII:T6V3LHY838) 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 (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
    ColorWHITE (OFF WHITE) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62372-500-30295 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33111/10/2016
    Labeler - Infirst Healthcare Inc. (079159739)
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