Label: MYLANTA NEW TONIGHT SOOTHING HONEY CHAMOMILE- calcium carbonate,magnesium hydroxide and simethicone suspension

  • NDC Code(s): 62372-510-10
  • 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 [10ml] dose)

    Calcium carbonate 800 mg

    Magnesium hydroxide 270 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: calcium 320 mg; magnesium 115 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, sucrose, xanthan gum

  • Questions or comments?

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

  • Principal Display Panel

    MYLANTA®
    LIQUID
    ANTACID
    +
    ANTI-GAS

    Tonight

    FAST RELIEF OF HEARTBURN AFTER DINNER

    Soothing Honey Chamomile Flavor

    10 FL OZ (296 mL)

    76710-TNT-MYLLF

    Mylanta® Tonight, with its soothing honey-chamomile flavor, is perfect for fast heartburn relief in the evening-the time of day when adults suffer heartburn and acid indigestion the most.

    Mylanta® Tonight is also non–drowsy, so you can use it any time of the day. The great-tasting, coating, soothing liquid helps make heartburn after-dinner feel better fast.

    •
    Calcium-rich formula
    •
    Paraben-free
    •
    Smooth, creamy taste

    Active ingredients: Calcium carbonate, Magnesium hydroxide, Simethicone

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

    76710-TNT-MYLLB

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

    infirst+
    HEALTHCARE

    Manufactured for:

    Infirst Healthcare Inc.
    Westport, CT 06880
    ©2022
    Infirst Healthcare Inc.
    Mylanta.com

    Mylanta Tonight Soothing Honey Chamomile Flavor 10 FL OZ
  • INGREDIENTS AND APPEARANCE
    MYLANTA NEW TONIGHT SOOTHING HONEY CHAMOMILE 
    calcium carbonate,magnesium hydroxide and simethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62372-510
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE800 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 (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITE (OFF WHITE) Score    
    ShapeSize
    FlavorHONEY (CHAMOMILE) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62372-510-10295 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/21/2016
    Labeler - Infirst Healthcare Inc. (079159739)
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