Label: INFANTS GAS RELIEF DROPS- simethicone emulsion

  • Category: HUMAN OTC DRUG LABEL

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 December 9, 2019

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  • Active ingredient (in each 0.3 mL)

    simethicone 20 mg

  • Purpose

    Antigas

  • Uses

    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 recommend 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 under2
    		under 24
    		0.3 mL
    children over 2
    		over 24
    		0.6 mL

  • Other information

    store at room temperature

  • Inactive ingredients

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

  • Questions?

    1-800-824-1706 Monday - Friday 9am-4pm MST.

    You may also report side effects to this phone number

  • Principal Display Panel

    *Compare to the active ingredient in MYLICON® Non-Staining Infants Drops

    Infants Gas Relief Drops

    SIMETHICONE 20 mg / ANTI-GAS

    Soothing Relief for: Pressure, Bloating & Gas Symptoms

    Alcohol Free

    Dye Free

    1 FL OZ (30 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    INFANTS GAS RELIEF DROPS 
    simethicone emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-218
    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
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-218-301 in 1 CARTON11/24/2014
    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 finalpart33211/24/2014
    Labeler - WinCo Foods, LLC (056098817)
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