Label: MEIJER INFANTS GAS RELIEF DROPS- simethicone emulsion

  • NDC Code(s): 41250-470-01
  • Packager: MEIJER DISTRIBUTION INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 1, 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 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, natural flavors, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum.

    Questions?

    1-866-467-2748

  • Principal Display Panel

    NDC 41250-470-01

    *Compare to active ingredient Infant’s Mylicon® Drops

    Infants'

    Gas Relief

    Drops

    Simethicone Drops / Anti-gas

    •
    Dye- free
    •
    Non-staining formula
    •
    No Saccharin
    •
    No Artificial Colors
    •
    No Artificial Flavors

    Actual product size on Side Panel

    1 FL. OZ. (30 mL)

    100 doses

    DISTRIBUTED BY:

    * 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
    Meijer Infants Gas Relief Simethicone
  • INGREDIENTS AND APPEARANCE
    MEIJER INFANTS GAS RELIEF DROPS 
    simethicone emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-470
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-470-011 in 1 CARTON06/29/2020
    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 DrugM00206/29/2020
    Labeler - MEIJER DISTRIBUTION INC. (006959555)
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