FDA Label for Infants Gas Relief Drops

View Indications, Usage & Precautions

Infants Gas Relief Drops Product Label

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


Otc - Keep Out Of Reach Of Children





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 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



Select Brand

Compare to the active ingredient in Infants Mylicon® Drops

Infant's Gas Relief Drops

Simethicone

Anti-Gas

Non-staining

Excess Gas relief

Alcohol Free

Saccharin Free

No Artificial Flaovr


1 fl oz (30 mL)


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