Label: CHILDRENS MYLICON TUMMY RELIEF FOR KIDS- antacid and antigas tablet, chewable

  • NDC Code(s): 62372-400-02, 62372-400-24
  • Packager: Infirst Healthcare Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 1, 2023

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  • Drug Facts

  • Active ingredients (in each tablet)

    Calcium carbonate 400 mg

    Simethicone 40 mg

  • Purposes

    Antacid

    Antigas

  • Uses

    relieves:

    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach associated with these symptoms
    • pressure and bloating commonly referred to as gas
    • overindulgence in food and drink
  • Warnings

    Ask a doctor or pharmacist before use if

    your child is 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

    • follow directions based on age/weight below
    • repeat as needed
    • do not use the maximum dosage for more than two weeks except under the advice and supervision of a doctor

    Weight

    Age

    Dosage

    under 24 lbs

    under 2 yrs

    ask a doctor

    24-47 lbs

    2-5 yrs

    1 tablet, Not more than 3 tablets in 24 hours

    48-95 lbs

    6-11 yrs

    2 tablets, Not more than 6 tablets in 24 hours
  • Other information

    • e ach chewable tablet contains:calcium 160 mg
    • store between 20-25°C (68-77°F)
  • Inactive ingredients

    adipic acid, crospovidone, D&C red 27, dextrose, flavors, magnesium stearate, maltodextrin, sucralose,

  • Questions or comments?

    call 1-855-848-3284 (English & Spanish)

  • Package/Label Principal Display Panel

    Children's Mylicon Tummy Relief for Kids

    Great tasting Chewable Tablets!

    • New!

    Children’s MYLICON ®Antacid/ Antigas

    Tummy Relief for Kids

    Works quickly to soothe upset tummies

    due to bloating, gas and discomfort

    from acid indigestion and overeating

    • Multi- Symptom Relief for Upset Tummies
    • Multi-Symptom Tummy Relief for Kids

    Cherry Flavor!

    24 CHEWABLE TABLETS Ages 2 to 11

    Important: Keep this carton for future reference on full labeling.

    Visit us at Mylicon.com

    Manufactured for:

    Infirst Healthcare Inc,

    Westport, CT 06880

    ©2018 Infirst Healthcare Inc.

    Mylicon is a registered trademark of McNeil Consumer Pharmaceuticals Co,

    TAMPER EVIDENT: do not use if imprinted safety seal under cap is broken or missing.

    Children Mylicon Pouch Pack

    Children Mylicon Tummy Relief
  • INGREDIENTS AND APPEARANCE
    CHILDRENS MYLICON TUMMY RELIEF FOR KIDS 
    antacid and antigas tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62372-400
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE400 mg
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE40 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Colorpink (Pinkish White) Scoreno score
    ShapeROUNDSize16mm
    FlavorCHERRYImprint Code myc
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62372-400-2424 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/09/2018
    2NDC:62372-400-022 in 1 POUCH; Type 0: Not a Combination Product09/24/201906/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00202/09/2018
    Labeler - Infirst Healthcare Inc. (079159739)
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