Label: PEDIACARE GAS RELIEF DROPS DYE FREE- simethicone emulsion and simethicone liquid

  • Category: HUMAN OTC DRUG LABEL

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 April 13, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    (in each 0.3 mL)

    Simethicone Emulsion USP 66.7mg/Simethicone 20 mg

  • Purpose

    Anti-Gas

  • 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

  • Directions

    • shake well before using
    • all dosages may be repeated as needed, after meals and at bedtime
    • fill enclosed dropper to recommended dosage level

    Dose by weight or if weight information is not available, dose by age.

    • dispense liquid slowly into baby’s mouth, toward inner cheek
    • may mix with 1 oz. of cool water, infant formula or other suitable liquids
    • clean dropper after each use and replace original cap
    age (yr)weight (lb)dose
    infants under 2under 240.3 mL
    children 2 and over24 and over0.6 mL
  • Other information

    • Do not freeze
    • Store at room temperature 20-25ºC (68-77ºF)
    • See bottle or box for lot number and expiration date
  • Inactive ingredients

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

  • Questions or comments?

    call 1-888-474-3099 Mon. – Fri. 8 am to 8 pm EST or visit us at PediaCare.com




  • PRINCIPAL DISPLAY PANEL

    INFANTS 0-36 months
    PediaCare® we care for kidsTM
    Gas Relief DROPS
    SIMETHICONE-ANTI GAS
    NON-STAINING
    1 FL OZ (30 mL)

    PRINCIPAL DISPLAY PANEL INFANTS 0-36 months PediaCare® we care for kidsTM Gas Relief DROPS SIMETHICONE-ANTI GAS NON-STAINING 1 FL OZ (30 mL)

  • INGREDIENTS AND APPEARANCE
    PEDIACARE GAS RELIEF DROPS DYE FREE 
    simethicone emulsion and simethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-811
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-811-011 in 1 BOX
    130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33208/01/2011
    Labeler - Medtech Products Inc. (122715688)
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