GAS RELIEF DROPS INFANTS (SIMETHICONE) EMULSION [MCKESSON]

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GAS RELIEF DROPS INFANTS (SIMETHICONE) EMULSION [MCKESSON]
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NDC 49348-740-27
Set ID a61f486b-0563-4cdf-9a56-e118e769e859
Category HUMAN OTC DRUG LABEL
Packager Strategic Sourcing Services LLC
Generic Name
Product Class
Product Number
Application Number PART332
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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 under2under 240.3 mL
    children over 2over 240.6 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

    sunmark

    COMPARE TO MYLICON NON-STAINING INFANTS' DROPS ACTIVE INGREDIENT

    NDC 49348-740-27

    gas relief drops infant's

    Fast relief of gas symptoms

    Alcohol and saccharin Free

    NON-STAINING FORMULA

    1 fl oz (30 mL) 100 DOSES

    image description

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF DROPS INFANTS  
    simethicone emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-740
    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:49348-740-271 in 1 CARTON09/26/2019
    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 finalpart33209/26/2019
    Labeler - Strategic Sourcing Services LLC (116956644)
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