Label: INFANTS GAS RELIEF DROPS- simethicone emulsion

  • NDC Code(s): 49035-709-01, 49035-709-30
  • Packager: Wal-Mart Stores,Inc.,
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 November 6, 2019

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 sign 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 any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
    remove cap and insert syringe into the prescribed level.
    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 chick.

    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.
    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

    *Compare to active ingredient in infant’s Mylicon® Drops

    Infants'

    Gas Relief

    Drops

    Simethicone 20 mg /Antigas

     
    Dye- free
     
    Non-staining
     
    Formula
     
    No Alcohol
    No Saccharin
    No Artificial Colors
    No Artificial Flavor

    1 FL. OZ. (30 mL) 100 doses

    Distributed by:

    Made in USA with domestic and imported ingredients.

    Factory certified.

    * This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ Mylicon® Drops.

     
    IMPORTANT: Keep this carton for future reference on full labeling
    Infant's Gas Relief Drop Simethicone Antigas

    Infants Gas Relief Drops

    Infants Gas Relief Drop
  • INGREDIENTS AND APPEARANCE
    INFANTS GAS RELIEF DROPS 
    simethicone emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-709
    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 FORM (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:49035-709-011 in 1 CARTON10/16/2017
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49035-709-301 in 1 CARTON10/22/2019
    230 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33210/16/2017
    Labeler - Wal-Mart Stores,Inc., (051957769)