Label: PEDIACARE SIMETHICONE ANTIGAS- simethicone emulsion

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated September 9, 2017

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  • Drug Facts

  • Active ingredient

    (in each 0.3 mL)

    Simethicone 20 mg

    (provided as simethicone emulsion 66.7 mg)

  • Purpose

    Antigas

  • Uses

    relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods

  • Warnings

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • shake well before using
    • find right dose on chart below. If possible, use weight to determine dose; otherwise, use age.
    • measure only with the enclosed syringe
    • remove cap and insert syringe into the bottle. Fill syringe to recommended dosage level.
    • dispense liquid slowly into child's mouth, toward inner cheek
    • may be mixed with 1 oz. of cool water, infant formula or other suitable liquids
    • 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
    • clean syringe and replace cap tightly on bottle
    • mL = millilitre
          Age(yrs)   
    		weight(lbs)
    		dose
    infants
    under 2
    		 under 24
    		 0.3mL
    children 2
    and over
    		 24 and over
    		 0.6mL
  • Other information

    • do not freeze
    • store at 20°-25°C (68°-77°F)
  • Inactive ingredients

    carboxymethylcellulose sodium, citric acid, flavor, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate , sucralose, xanthan gum

  • Questions

    1-888-474-3099 

    Monday – Friday 8 am to 5 pm

    Eastern standard time.

    PediaCare.com

  • Principal Display Panel

    INFANTS 0-36 months

    PediaCare® 

    Gas Relief DROPS

    SIMETHICONE-ANTIGAS

    DYE-FREE Berry Flavor

    1 FL OZ (30 mL)

    Carton

    Carton

    Label

    Label

  • INGREDIENTS AND APPEARANCE
    PEDIACARE SIMETHICONE ANTIGAS 
    simethicone emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-853
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE0.011 g  in 1 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.211 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59556-853-5930 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33208/01/2011
    Labeler - Strides Pharma Inc (078868278)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC001207208MANUFACTURE(59556-853)
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