Label: INFANTS GAS RELIEF DYE FREE- simethicone antigas emulsion

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

Drug Label Information

Updated July 29, 2024

If you are a consumer or patient please visit this version.

  • 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.
    • all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician.
    • do not exceed 12 doses per day.
    • Fill enclosed dropper or syringe to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
    • dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
    • clean dropper well after each use-recap bottle with original cap
    • 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

    Comments or Questions?

    855-200-BABY

    www.ComfortsForBaby.com

  • Principal Display Panel

    NDC# 30142-171-01

    Dye Free Drops

    INFANTS’ GAS RELIEF

    *compare to the active ingredient of INFANTS’ MYLICON ®DROPS

    *see the side panel

    Dye Free Drops

    INFANTS’ GAS RELIEF

    SIMETHICONE-ANTIGAS

    • Non-Staining formula
    • Gently Breaks Down Baby’s Gas Bubbles
    • No alcohol
    • No Artificial Colors or Flavor

    1 Fl. OZ (30ml)

    100 DOSES

    IMPORTANT:Keep this carton for future reference on full labeling

    DISTRIBUTED BY THE KROGER CO.

    CINCINNATI, OHIO 45202

    *THIS PRODUCT IS NOT MANUFACTURED OR DISTRIBUTED BY INFIRST HEALTHCARE INC., THE DISTRIBUTOR OF INFANTS’ MYLICON ®DROPS. INFIRST HEALTHCARE INC. IS NOT AFFILIATED WITH THE KROGER CO. OR THIS PRODUCT.

    Kroger Infants Gas Relief Drops
  • INGREDIENTS AND APPEARANCE
    INFANTS GAS RELIEF   DYE FREE
    simethicone antigas emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-171
    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
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-171-011 in 1 CARTON07/16/2019
    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 DrugM00207/16/2019
    Labeler - THE KROGER CO. (006999528)