Label: MYLANTA ALL-FAMILY MULTI SYMPTOM STOMACH REMEDY- calcium carbonate, simethicone liquid

  • NDC Code(s): 62372-520-16
  • Packager: Infirst Healthcare Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 22, 2024

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    (in each 10 mL dose)

    Calcium carbonate 800 mg

    Simethicone Emulsion 266.6 mg/ Simethicone 80 mg

  • PURPOSE

    Purposes

    Antacid

    Anti-gas

  • INDICATIONS & USAGE

    Uses relieves:

    • heartburn • acid indigestion • sour stomach

    • upset stomach due to thse symptoms

    • pressure and bloating commonly referred to as gas

    • overindulgence in food and drink

  • WARNINGS

    Warnings

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • shake well before use • measure with dosing cup provided

    • take as needed, between meals, at bedtime or as directed by a doctor

    • do not use the maximum dosage for more than 2 weeks

    • follow directions based on age below

    AgeDosage
    children ages 6-11 yrs10 mL. Not to exceed more than 30 mL in 24 hours
    adults and children 12 yrs of age and over10-20 mL. Not to exceed more than 60 mL in 24 hours

    • mL=milliliter

  • Other information

    • each 10 mL dose contains:

    calcium 320 mg; sodium 5 mg

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

  • INACTIVE INGREDIENT

    Inactive ingredients

    benzyl alcohol, carboxymethylcellulose sodium, D&C red no. 28, flavor, glycerin, microcrystalline cellulose, purified water, sodium carbonate, sorbitol, sucralose, xanthan gum

  • QUESTIONS

    Questions or comments? call 1-844-695-6624

    toll free (English and Spanish)

  • SPL UNCLASSIFIED SECTION

    Great-tasting

    All-Family Mylanta ®

    QUICKLY SOOTHES for fast relief

    MULTI-SYMPTOM RELIEF

    of heartburn, gas, and upset stomachs

    due to overindulgence in food and drink

    GREAT-TASTING mixed berry flavor

    ACTIVE INGREDIENTS:

    CALCIUM CARBONATE, SIMETHICONE

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

    infirst +™

    Manufactured for:

    Infirst Healthcare Inc.

    Westport, CT 06880

    2024 Infirst Healthcare Inc.

    ©Mylanta.com

    Lot:

    Exp:

  • PRINCIPAL DISPLAY PANEL

    VALUE SIZE

    ALL-FAMILY

    Mylanta ®

    ANTACID+ANTI-GAS

    MULTI-SYMPTOM

    STOMACH REMEDY

    Fast Relief of Heartburn,

    Gas, and Upset Stomachs

    for Adults & Children

    Ages 6+

    MIXED BERRY FLAVOR

    16 FL OZ (473 mL)

    label

    drug facts

  • INGREDIENTS AND APPEARANCE
    MYLANTA  ALL-FAMILY MULTI SYMPTOM STOMACH REMEDY
    calcium carbonate, simethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62372-520
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE800 mg  in 10 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorBERRY (Mixed) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62372-520-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/21/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00105/21/2024
    Labeler - Infirst Healthcare Inc. (079159739)
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