FDA Label for Gas-aid Drops For Infants

View Indications, Usage & Precautions

Gas-aid Drops For Infants Product Label

The following document was submitted to the FDA by the labeler of this product Leosons. 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


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 immediately.


Directions



  • shake well before using
  • all dosages may be repeated as needed, after meals and at bedtime
  • fill enclosed dropper to recommend 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 under2 under 24 0.3 mL
     children over 2 over 24

     0.6 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



Gas-Aid drops for infant's

Fast relief of

Simethicone Anti-Gas

No Saccharin or artificial flavor

Alcohol and dye Free

Non-staining

1 fl oz (30 mL)


* Please review the disclaimer below.