Label: MYLANTA VANILLA CARAMEL- calcium carbonate, magnesium hydroxide, simethicone liquid

  • NDC Code(s): 62372-541-12
  • Packager: Infirst Healthcare Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 5, 2024

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  • Drug Facts

  • Active ingredients

    Calcium carbonate 800 mg

    Magnesium hydroxide 270 mg

    Simethicone 80 mg

  • Purposes

    Antacid

    Antacid

    Anti-gas

  • Uses

    relieves:

    • heartburn • acid indigestion • sour stomach

    • upset stomach due to these symptoms

    • pressure and bloating commonly referred to as gas

    • 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) as needed, 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:

    calcium 335 mg; magnesium 120 mg; sodium 8 mg

    • store between 20-25°C (68-77°F), do not freeze

  • Inactive ingredients

    benzoic acid, benzyl alcohol, edetate disodium, flavor, glycerin, glyceryl monostearate, methylcellulose, microcrystalline cellulose, peg-8 stearate, polysorbate 65, purified water, sodium benzoate, sorbic acid, sucralose, xanthan gum

  • Questions or comments?

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

  • SPL UNCLASSIFIED SECTION

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

    infirst +

    HEALTHCARE®

    Manufactured for:

    Infirst Healthcare Inc.

    Westport, CT 06880

    ©2023 Infirst Healthcare Inc.

    Mylanta.com

    Lot:

    Exp:

  • PRINCIPAL DISPLAY PANEL

    Mylanta ®

    LIQUID ANTACID+ANTI-GAS

    WORKS ON CONTACT!

    Fast relief of heartburn, acid indigestion, and painful gas.

    VANILLA CARAMEL FLAVOR

    12 FL OZ (355 mL)

    label

  • INGREDIENTS AND APPEARANCE
    MYLANTA VANILLA CARAMEL 
    calcium carbonate, magnesium hydroxide, simethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62372-541
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION800 mg  in 10 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg  in 10 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE270 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)  
    PEG-8 STEARATE (UNII: 2P9L47VI5E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBIC ACID (UNII: X045WJ989B)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POLYSORBATE 65 (UNII: 14BGY2Y3MJ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorVANILLA (Caramel) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62372-541-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product01/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00101/31/2024
    Labeler - Infirst Healthcare Inc. (079159739)
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