MYLANTA NEW TONIGHT SOOTHING HONEY CHAMOMILE (CALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONE) SUSPENSION [INFIRST HEALTHCARE INC.]

MYLANTA NEW TONIGHT SOOTHING HONEY CHAMOMILE (CALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONE) SUSPENSION [INFIRST HEALTHCARE INC.]
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NDC 62372-510-12
Set ID 123f3005-a0a0-4970-94f1-f6d04741078b
Category HUMAN OTC DRUG LABEL
Packager Infirst Healthcare Inc.
Generic Name
Product Class
Product Number
Application Number PART331
  • Active ingredients (in each 10 mL 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
     
    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:

    calcium 320 mg; magnesium 115mg; 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 Tonight

    ANTACID + ANTI-GAS

    FAST RELIEF OF HEARTBURN AFTER DINNER

    Soothing Honey Chamomile Flavor

    12 FL OZ (355mL)

    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, soothing liquid, with extra coating power, helps make after-dinner heartburn 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


    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 Tonight Liquid Antacid  Anti-Gas 12 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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    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:62372-510-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/21/2016
    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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