Label: SUNMARK INFANTS GAS RELIEF DROPS- 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 September 10, 2012

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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

  • Warnings


    When using this product

    do not exceed 12 doses per day

    Keep out of the reach of children.


  • Directions

    • shake well before using
    • all dosages may be repeated as needed, after meals and at bedtime
    • fill enclosed dropper to recommended 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 replace original cap.
      age (yr)   weight (lb)    
      		dose             
      infants under 2   
      		under 24   0.3 mL
      children over 2   
      		over 24   0.6 mL
  • Other information

    store at room temperature (59oF-86oF)

  • Inactive ingredients

    benzoic acid, red # 22, red # 28, flavor, magnesium aluminum silicate, purified water, sorbitol, xanthan gum.


  • Principal Display Panel

    Sunmark

    compare to Mylicon® Infant drops active ingredient

    gas relief drops infants'

    Fast relief of gas symptoms

    Alcohol and Saccharin free

    No artificial flavor

    1 fl oz (30 mL) 100 Dosesinfants gas relief drug factsinfants gas relief

  • INGREDIENTS AND APPEARANCE
    SUNMARK INFANTS GAS RELIEF DROPS 
    simethicone emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-577
    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)  
    D&C RED NO. 22 (UNII: 1678RKX8RT)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-577-341 in 1 CARTON
    130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33210/31/2003
    Labeler - McKesson (177667227)
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