FDA Label for Infants Non-staining Gas Relief

View Indications, Usage & Precautions

Infants Non-staining Gas Relief Product Label

The following document was submitted to the FDA by the labeler of this product H E B. 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


Use(S)



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 overdose, get medical help or contact a Poison Control Center right away


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 and close the bottle to maintain child resistance

  •  age (yr)weight (lb)dose
     infants under 2 under 240.3 mL
     children over 2over 240.6 mL

Other Information



store at room temperature


Inactive Ingredient Section



benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum


Principal Display Panel



Compare to Infants' Mylicon® Drops Non-Staining active ingredient*

NDC 37808-014-09


HEB

Infants' Non-Staining

Gas Relief

Drops

simethicone 20 mg 

Anti-Gas


  • Fast Relief of Gas Symptoms
  • No Artificial flavor
  • Gentle & Safe**
  • Alcohol Free
  • Dye free
  • **Use only as directed, do not exceed more than 12 doses per day.


    1 FL OZ (30 mL)


* Please review the disclaimer below.