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  5. Label Information: Harris Teeter Infants Gas Relief

FDA Label for Harris Teeter Infants Gas Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 0.3 ML)
    2. PURPOSE
    3. USES
    4. WHEN USING THIS PRODUCT
    5. KEEP OUT OF REACH OF CHILDREN.
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS?
    10. PRINCIPAL DISPLAY PANEL

Harris Teeter Infants Gas Relief Product Label

The following document was submitted to the FDA by the labeler of this product Harris Teeter, Llc. 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 right away. (1-800-222-1222)


Directions



  • •shake well before using
  • •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 to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek
  • •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

    • Age (yr)

    Weight (lb)

    Dose

    infants under 2

    under 24

    0.3 mL

    children over 2

    over 24

    0.6 mL


Other Information



  • •store at 20-25°C (68-77°F)
  • •do not use if printed bottle wrap is broken or missing

Inactive Ingredients



anhydrous citric acid, flavor, hypromellose, maltitol solution, purified water, simethicone emulsion, sodium benzoate, sodium citrate, xanthan gum


Questions?



1-800-432-6111


Principal Display Panel



INFANTS’

GAS RELIEF

Simethicone 20 mg

Anti-Gas

Dye-Free Drops

Non-Staining

Gently Breaks Down Baby’s Gas Bubbles

Safe Enough To Use At Every Feeding**

Pediatrician Recommended #1 Active Ingredient

Compare to the active ingredient in Mylicon®

**use as directed

1 FL OZ (30 mL)


* Please review the disclaimer below.