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  5. Label Information: Infants Gas Relief Original Formula

FDA Label for Infants Gas Relief Original Formula

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH 0.3 ML)
    3. PURPOSE
    4. USES
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. PRINCIPAL DISPLAY PANEL - 30 ML BOTTLE CARTON

Infants Gas Relief Original Formula Product Label

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

Other



Drug Facts

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895


Active Ingredient (In Each 0.3 Ml)



Simethicone 20 mg


Purpose



Anti-gas


Uses



Relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.


Otc - Keep Out Of Reach Of Children



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 doses 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 be mixed with 1 oz. of cool water, infant formula or other suitable liquids
  • for best results, clean dropper after each use and replace original cap
    • Age (yr)Weight (lb)Dose
    infants under 2under 240.3 mL
    children over 2over 240.6 mL

Other Information



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

Inactive Ingredients



Carbomer 934-P, Citric Acid, Hydroxypropyl Methylcellulose, Natural Flavors, Purified Water, Red #3, Sodium Benzoate, Sodium Citrate, Sucralose


Principal Display Panel - 30 Ml Bottle Carton



CVS
pharmacy®

Compare to the
active ingredient in
Infants' MYLICON® Drops*

Infants'
GAS
RELIEF
ORIGINAL FORMULA

SIMETHICONE/ANTIGAS

* Please review the disclaimer below.