Quita Colicos Gas Relief Drops Liquid
FDA Label NDC 24286-1533

10 label sections · Submitted to the FDA by Dlc Laboratories, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dlc Laboratories, Inc. for the product Quita Colicos Gas Relief Drops (NDC 24286-1533). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each 0.3 ml), purpose, uses, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

INFANTS (under 2 years): 0.3 mL

Image (Gasreliefdrops 01)

Image (Gasreliefdrops 01)

CHILDREN (over 2 years): 0.6 mL

AGE (years)WEIGHT (lbs.)DOSE
INFANTS under 2Under 24 lbs.0.3 mL
CHILDREN over 2More than 24 lbs.0.6 mL

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. If possible, use weight to dose; otherwise, use age.
  • only use the enclosed dropper.Fill dropper to the recommended dosage level and dispense liquid slowly into baby's mouth, toward the inner cheek.
  • 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
  • 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

    • mL = milliliter

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

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