FDA Label for Quita Colicos Gas Relief Drops

View Indications, Usage & Precautions

Quita Colicos Gas Relief Drops Product Label

The following document was submitted to the FDA by the labeler of this product Dlc Laboratories, Inc.. 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.

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Drug Facts

Manufactured by
De La Cruz Products
A Division of DLC Laboratories, Inc.
Paramount, CA 90723 USA


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


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.


Directions



  • SHAKE WELL BEFORE USING
  • find right dose on chart
  • all dosages may be repeated as needed, after meals and at bedtime or as directed by a doctor. Do not exceed 12 doses per day.
  • fill enclosed dropper to the recommended dosage level and dispense liquid slowly into baby's mouth, toward the inner cheek
  • dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids
  • clean dropper well after each use and replace original cap
  • Age (yr)Weight (lb)Dose
    Infants under 2Under 24 lbs.0.3 mL
    Children over 2Over 24 lbs.0.6 mL

Other Information



  • do not use if printed bottle wrap is missing or broken
  • store at room temperature
  • do not freeze
  • see bottom panel for lot number and expiration date

Inactive Ingredients



citric acid, hydroxypropyl methylcellulose, maltitol, natural flavor, purified water USP, sodium benzoate, sodium citrate, xanthan gum


Questions?



1-800-858-3889


Principal Display Panel - 30 Ml Bottle Box



De La Cruz®

Gas Relief
Drops

Quita Cólicos®
Gotas

Safe
For Newborns

Simethicone
Anti Gas

Gas Relief Drops For
Newborns, Infants & Children

Up to 100 doses
1 FL OZ (30 mL)


* Please review the disclaimer below.