Label: GOOD SENSE SIMETHICONE INFANTS- simethicone emulsion

  • 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 27, 2018

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 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 (1-800-222-1222).

  • 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 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

    do not use if printed bottle wrap is broken or missing
    store at 20-25°C (68-77°F)
    do not freeze
  • Inactive ingredients

    anhydrous citric acid, flavor, hypromellose, maltitol solution, purified water, simethicone emulsion, sodium benzoate, sodium citrate, xanthan gum

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Gas Relief

    Pediatrician Recommended #1 Active Ingredient

    Infants’ Simethicone Drops

    Simethicone 20 mg

    Anti-Gas

    Gently Breaks Down Baby’s Gas Bubbles

    Safe Enough to Use at Every Feeding**

    Non-Staining

    Dye Free Drops

    Compare to active ingredient of Infants’ Mylicon® Drops

    100% SATISFACTION GUARANTEED

    1 FL OZ (30 mL)

    **Use as Directed

    infants simethicone drops image
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE SIMETHICONE  INFANTS
    simethicone emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0882
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    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:0113-0882-101 in 1 CARTON02/23/2000
    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 finalpart33202/23/2000
    Labeler - L. Perrigo Company (006013346)