Label: WALGREENS INFANTS DYE FREE GAS RELIEF- simethicone emulsion

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

Drug Label Information

Updated November 28, 2023

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  • Active ingredient (in each 0.3 mL)

    Simethicone 20 mg

  • Purpose

    Antigas

  • Uses

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

  • Warnings

    Keep out of reach of children.
    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
    Quick medical attention is critical even if you do not notice any signs or symptoms

  • Directions

    •
    shake well before using
    •
    find right dose on chart below. if possible, use weight to dose; otherwise use age.
    •
    only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
    •
    remove cap and insert syringe into the bottle.
    •
    pull syringe up until filled to the prescribed level, if you pass the prescribed level, simply push syringe back until you have reached the desired level, Slowly dispense the liquid into your child’s mouth (towards inner cheek)
    •
    all dosages may be repeated needed, after meals and at bedtime or as directed by a physician.
    •
    do not exceed 12 doses per day.
    •
    dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
    •
    replace cap tightly to maintain child resistance
    •
    mL= milliliter

    Age (yr)

    Weight (lb)

    Dose( mL)

    infants under 2

    under 24

    0.3

    children over 2

    over 24

    0.6
  • Other information

    •
    tamper evident: do not use if printed seal under cap is broken or missing
    •
    store at room temperature
    •
    do not freeze
    •
    see bottom panel for lot number and expiration date
  • Inactive ingredients

    carboxymethylcellulose sodium, citric acid, microcrystalline cellulose, natural flavors, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum.

    Questions?

    1-866-467-2748

  • Principal Display Panel

    Walgreens

    Compare to infant’s Mylicon Gas Relief active ingredient††

    Infants'

    Dye- Free

    Gas Relief

    Simethicone 20 mg PER DOSE /ANTI-GAS

     
    DYE FREE
     
    NONSTAINING FORMULA
     
    ALCOHOL FREE
    •
    No saccharin
    •
    No artificial flavor
    •
    Includes dosing syringe

    100 DOSES DYE FREE

    1 FL OZ (30 mL)

    200 WILMOT RD., DEERFIELD, IL 60015

    100% SATISFACTION GUARANTEED

    Walgreens.com ©2017 Walgreen Co,

    WALGREENS PHARMACIST RECOMMENDED‡

    ‡Walgreens Pharmacist Survey

    ‡‡ This product is not manufactured or distributed by infirst Healthcare Inc., the distributor of Infants’ Mylicon® Gas Relief.

     
    IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING
    infants' Dye-Free Gas Relief Simethicone 20 mg PER DOSE /ANTI GAS 100 Doses 1 FL OZ (30 mL)
  • INGREDIENTS AND APPEARANCE
    WALGREENS INFANTS DYE FREE GAS RELIEF 
    simethicone emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0790
    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
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITE (white to off white, opaque) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0790-301 in 1 CARTON08/30/2017
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00208/30/2017
    Labeler - WALGREEN CO. (008965063)
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