FDA Label for Quality Choice Infants Non-staining Gas Relief

View Indications, Usage & Precautions

Quality Choice Infants Non-staining Gas Relief Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association Inc.. 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 Ingredients



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


Principal Display Panel



NDC 63868-112-01

QC

Quality Choice 

*Compare to the Active Ingredient in Mylicon® 

Non-Staining Infants' Drops


Infants' Non-Staining

Gas Relief Drops

Antigas

Simethicone 20 mg


Fast Relief of Gas Symptoms 

No Artificial Flavor 

Alcohol Free

Dye Free

Gentle & Safe**

**Use only as directed;

do not exceed 12 doses per day.

1 FL OZ (30mL)




* Please review the disclaimer below.