Label: LEADER INFANTS GAS RELIEF- dimethicone emulsion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/09

If you are a consumer or patient please visit this version.

  • Active ingredient (in each 0.3 mL)

    Simethicone 20 mg

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  • Purpose

    Antigas

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  • Uses

    Relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods

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  • Warnings

    Keep out of reach of children. In case of overdose get medical help or contact a poison control center right away.

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  • Directions

    • shake well before using
    • 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.
    • fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek
    • dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
    • clean dropper after each use - replace bottle with original cap
    age (yr) weight (lb) dose
    infants under 2 under 24 0.3 mL
    children over 2 over 24 0.6 mL
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  • Other information

    • do not use in printed seal under cap is torn or missing
    • store at room temperature
    • do not freeze
    • see bottom panel for lot and expiration date
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  • Inactive ingredients

    carboxymethylcellulose sodium, citric acid, microcrystalline cellulose, natural flavors, PEG-40 monostearate, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol.

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  • Principal Display Panel

    Compare to Infants' Mylicon Drops active ingredient

    Infants' Gas Relief Drops

    Anti-gas/Simethicone

    Non-Staining

    suitable for infant use

    no artificial colors

    no saccharin

    alcohol free

    1 Fl. OZ (30ml)

    Leader Infants' Gas Relief
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  • INGREDIENTS AND APPEARANCE
    LEADER INFANTS GAS RELIEF 
    simethicone emulsion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37205-119
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (DIMETHICONE) DIMETHICONE 20 mg  in 0.3 mL
    Inactive Ingredients
    Ingredient Name Strength
    CARBOXYMETHYLCELLULOSE SODIUM  
    ANHYDROUS CITRIC ACID  
    CELLULOSE, MICROCRYSTALLINE  
    PEG-40 STEARATE  
    POTASSIUM SORBATE  
    WATER  
    SODIUM BENZOATE  
    SORBITAN MONOSTEARATE  
    SORBITOL  
    Product Characteristics
    Color WHITE (white to off white, opaque) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37205-119-10 1 in 1 CARTON
    1 30 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part332 03/08/2010
    Labeler - Cardinal Health (097537435)
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