FDA Label for Sunmark Infants Gas Relief Drops

View Indications, Usage & Precautions

Sunmark Infants Gas Relief Drops Product Label

The following document was submitted to the FDA by the labeler of this product Mckesson. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 Doses


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