Label: GAS-AID DROPS FOR 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 13, 2019

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  • 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

  • KEEP OUT OF REACH OF CHILDREN

  • 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 immediately.

  • Directions

    • shake well before using
    • all dosages may be repeated as needed, after meals and at bedtime
    • fill enclosed dropper to recommend dosage level
    • dispense liquid slowly into baby's mouth, toward the inner cheek
    • may mix with 1 oz. of cool water, infant formula or other suitable liquids
    • clean dropper after each use and close the bottle to maintain child resistance
     age (yr)                                 weight (lb)                            dose
     infants under2 under 24 0.3 mL
     children over 2 over 24

     0.6 mL                                                               

  • Other information

    store at room temperature

  • Inactive ingredients

    benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum

  • Principal Display Panel

    Gas-Aid drops for infant's

    Fast relief of

    Simethicone Anti-Gas

    No Saccharin or artificial flavor

    Alcohol and dye Free

    Non-staining

    1 fl oz (30 mL)

    Box

  • INGREDIENTS AND APPEARANCE
    GAS-AID DROPS FOR INFANTS 
    simethicone emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69626-5200
    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
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69626-5200-91 in 1 CARTON08/08/2015
    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 finalpart33208/08/2015
    Labeler - Leosons (148605470)
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