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  5. Label Information: Infants Gas Relief Dye Free

FDA Label for Infants Gas Relief Dye Free

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 0.3 ML)
    2. PURPOSE
    3. USES
    4. DIRECTIONS
    5. OTHER INFORMATION
    6. INACTIVE INGREDIENTS
    7. COMMENTS OR QUESTIONS?
    8. PRINCIPAL DISPLAY PANEL

Infants Gas Relief Dye Free Product Label

The following document was submitted to the FDA by the labeler of this product The Kroger Co.. 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 discomfort of infant gas frequently caused by air swallowing or certain formulas or foods


Directions



  • •shake well before using
  • •find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • •all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician.
  • •do not exceed 12 doses per day.
  • •Fill enclosed dropper or syringe to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • •dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
  • •clean dropper well after each use-recap bottle with original cap
  • •mL = milliliter

    • Age (yr)

    Weight (lb)

    Dose (mL)

    infants under 2

    under 24

    0.3

    children over 2

    over 24

    0.6


Other Information



  • •tamper evident: do not use if printed seal under cap is broken or missing
  • •store at room temperature
  • •do not freeze
  • •see bottom panel for lot number and expiration date

Inactive Ingredients



carboxymethylcellulose sodium, citric acid, microcrystalline cellulose, natural flavors, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum


Comments Or Questions?



855-200-BABY

www.ComfortsForBaby.com


Principal Display Panel



NDC# 30142-171-01

Dye Free Drops

INFANTS’ GAS RELIEF

*compare to the active ingredient of INFANTS’ MYLICON® DROPS

*see the side panel

Dye Free Drops

INFANTS’ GAS RELIEF

SIMETHICONE-ANTIGAS

  • •Non-Staining formula
  • •Gently Breaks Down Baby’s Gas Bubbles
  • •No alcohol
  • •No Artificial Colors or Flavor

    • 1 Fl. OZ (30ml)

    100 DOSES

    IMPORTANT: Keep this carton for future reference on full labeling

    DISTRIBUTED BY THE KROGER CO.

    CINCINNATI, OHIO 45202

    *THIS PRODUCT IS NOT MANUFACTURED OR DISTRIBUTED BY INFIRST HEALTHCARE INC., THE DISTRIBUTOR OF INFANTS’ MYLICON® DROPS. INFIRST HEALTHCARE INC. IS NOT AFFILIATED WITH THE KROGER CO. OR THIS PRODUCT.

    Infant's Dye Free Gas Relief Drops 100 Doses - 766DF30MYLFC

    Infant's Dye Free Gas Relief Drops 100 Doses - 766DF30MYLFC


* Please review the disclaimer below.