Publix Infants Dye Free Emulsion
FDA Label NDC 41415-709

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Publix Super Markets, Inc for the product Publix Infants Dye Free (NDC 41415-709). 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 active ingredient (in each 0.3 ml), purpose, uses, directions, other information, inactive ingredients, questions or comments ?, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.
  • only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • remove cap and insert syringe into the bottle
  • pull syringe up until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child’s mouth (toward inner cheek).
  • 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.
  • dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
  • replace cap tightly to maintain child resistance
  • 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, flavors, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum

Questions Or Comments ?

Call 1-866-467-2748

Principal Display Panel

NDC# 41415-709-01

Publix®

*Compare to the Active Ingredient in Infants’ Mylicon® Drops

INFANTS’ GAS RELIEF

DYE-FREE DROPS

SIMETHICONE ANTIGAS 20 MG/Antigas

  • No alcohol
  • No Saccharin
  • No Artificial Colors & Flavor
  • Non-Staining formula

    • 1 Fl. OZ (30ml)

    Syringe Enclosed.

    This bottle contains 100 doses (0.3 mL/dose)

    IMPORTANT: Keep this carton for future reference on full labeling

    DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,

    3300 PUBLIX CORPORATE PARKWAY

    LAKELAND, FL 33811

    1-888-267-3037 publix.com

    PUBLIX GUARANTEE: COMPLETE SATISFACTION OR YOUR MONEY BACK

    *This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ Mylicon® Drops.

    Publix Infant Gas Relief Drops (766df30mylfc)

    Publix Infant Gas Relief Drops (766df30mylfc)

* Please review the disclaimer below.