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 September 5, 2014

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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 immediately.

  • 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

  • Principal Display Panel

    Select Brand

    Compare to the active ingredient in Infants Mylicon® Drops

    Infant's Gas Relief Drops

    Simethicone

    Anti-Gas

    Non-staining

    Excess Gas relief

    Alcohol Free

    Saccharin Free

    No Artificial Flaovr


    1 fl oz (30 mL)

    BOX

  • INGREDIENTS AND APPEARANCE
    INFANTS GAS RELIEF DROPS 
    simethicone emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-042
    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:15127-042-171 in 1 CARTON
    130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33202/02/2013
    Labeler - Select Brand (043562370)
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