MYLANTA MAXIMUM STRENGTH CLASSIC FLAVOR (ANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONE) SUSPENSION [INFIRST HEALTHCARE INC.]

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  • MYLANTA MAXIMUM STRENGTH CLASSIC FLAVOR (ANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONE) SUSPENSION [INFIRST HEALTHCARE INC.]

MYLANTA MAXIMUM STRENGTH CLASSIC FLAVOR (ANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONE) SUSPENSION [INFIRST HEALTHCARE INC.]
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NDC 62372-500-12
Set ID 56853b20-a2aa-4b19-a428-3dde232114c6
Category HUMAN OTC DRUG LABEL
Packager Infirst Healthcare Inc.
Generic Name
Product Class
Product Number
Application Number PART331
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  • Active ingredients (in each 10 mL 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
     
    measure with dosing cup provided
     
    adults and children 12 years and over: 10 mL-20 mL (1-2 doses) between meals, at bedtime 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
     
    mL= milliliter
  • 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 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 Flavor

    12 FL OZ (355mL)

    Also try Mylanta Maximum Strength Vanilla Caramel Flavor

    and

    Mylanta Tonight, with its soothing taste of Honey-Chamomile, is perfect for heartburn relief after dinner

    and

    Mylanta GasMinis ̶ great- tasting mini- tablets that relieve gas symptoms fast

    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.

    •
    Multi-symptom relief
    •
    Extra coating power
    •
    Paraben- free

    Active ingredients: Aluminum hydroxide, Magnesium hydroxide, Simethicone

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


    Mylanta is a registered trademark of McNeil Consumer Pharmaceuticals Co.

    infirst+

    HEALTHCARE

    Manufactured for:

    Infirst Healthcare Inc.

    Westport, CT 06880

    ©2017 Infirst Healthcare Inc.

    Mylanta.com

    Mylanta Maximum Strength Classic Flavor 12 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 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
    ColorWHITE (OFF WHITE) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62372-500-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/10/2016
    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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