Label: MYLANTA COAT AND COOL- calcium carbonate, magnesium hydroxide, simethicone liquid

  • NDC Code(s): 62372-796-12
  • Packager: INFIRST HEALTHCARE INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2024

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  • Drug Facts

  • Active ingredient (in 10 mL dose)

    Calcium Carbonate 1200 mg

    Magnesium Hydroxide 270 mg

    Simethicone 80 mg

  • Purpose

    Antacid

    Antacid

    Anti-gas

  • Uses

    • relieves:
      • acid indigestion
      • heartburn
      • 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 using
    • Measure with dosing cup provided
    • adults and children12 years and over:take 10-20 mL (1-2 doses) between meals, at bedtime, or as directed by a doctor
    • do not take more than 60 mL in 24 hours 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 480 mg; magnesium 115 mg; sodium 4 mg
    • store between 20-25°C (68-77°F), do not freeze.
  • Inactive ingredients

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

  • Questions or comments?

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

  • Principal Display Panel

    Mylanta ®

    NDC# 62372-796-12

    NEW! Coat & Cool™

    2X COATING POWER

    CHOCOLATE MINT FLAVOR

    WORKS ON CONTACT!

    Coats & cools to relieve heartburn fast

    Smooth chalky taste

    12 FL OZ (355 mL)

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

    Mylanta® is Registered Trademark of McNeil Consumer Pharmaceuticals Co.

    Infirst

    HEALTHCARE

    Manufactured for:

    Infirst Healthcare Inc.

    Westport, CT 06880

    © 2019 Infirst Healthcare Inc.

    Mylanta.com

    Mylanta Coat & Cool Chocolate Mint Flavor
  • INGREDIENTS AND APPEARANCE
    MYLANTA COAT AND COOL 
    calcium carbonate, magnesium hydroxide, simethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62372-796
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE1200 mg  in 10 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE270 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)  
    PECTIN (UNII: 89NA02M4RX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHOCOLATE (MINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62372-796-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/28/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00110/28/2019
    Labeler - INFIRST HEALTHCARE INC. (079159739)
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