Label: INFANTS GAS RELIEF- simethicone solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 5, 2025

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  • ACTIVE INGREDIENT (in each 0.3 mL)

    Simethicone 20 mg

  • PURPOSE

    Antigas

  • USE(S)

    relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods


  • WARNINGS

    When using this product do not exceed 12 doses per day

  • KEEP OUT OF REACH OF CHILDREN

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • shake well before using
    • all dosages may be repeated as needed, after meals and at bedtime 
    • fill enclosed dropper to recommended dosage level
    • dispense liquid slowly into baby's mouth, toward the inner cheek
    • may mix with 1 oz. of cool water, infant formula or other suitable liquids
    • clean dropper after each use and close the bottle to maintain child resistance

     age (yr)weight (lb)dose
     infants under 2 under 240.3 mL
     children over 2over 240.6 mL
  • OTHER INFORMATION

    store at room temperature

  • INACTIVE INGREDIENT SECTION

    benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum.

  • PRINCIPAL DISPLAY PANEL

    Harris Teeter™


    NDC 69256-520-09



    INFANTS'

    GAS RELIEF DROPS

    Antigas

    Simethicone 20 mg

     

    Fast Relief of Gas Symptoms

    No Artificial Flavor

    Alcohol Free

    Dye Free

    Gentle & Safe**


    Compare to the Active Ingredient in Mylicon® 

    Non-Staining Infants' Drops*


    **Use only as directed;

    do not exceed 12 doses per day.

    1 FL OZ (30mL)


    520-ht.jpg

     


  • INGREDIENTS AND APPEARANCE
    INFANTS GAS RELIEF 
    simethicone solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69256-520
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 0.3 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITE (off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69256-520-091 in 1 CARTON02/05/2025
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00202/05/2025
    Labeler - Harris Teeter, LLC (048463103)
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