Infants Gas Relief Drops Emulsion
FDA Label NDC 55910-790

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dolgencorp Inc for the product Infants Gas Relief Drops (NDC 55910-790). 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?, 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 any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • ▪remove cap and insert syringe into the prescribed level.
  • ▪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 (towards inner chick).

  • ▪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, natural flavors, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum.

Questions?

1-866-467-2748

Principal Display Panel

NDC 55910-790-01

*Compare to active ingredient in infant’s Mylicon® Drops

Infants'

Gas Relief

Drops

Simethicone 20 mg /Antigas

  •  Dye- free
  •  Non-staining
  •  Formula
    • No Saccharin
    • No Artificial Colors
    • No Artificial Flavor

      • 1 FL. OZ. (30 mL)

      100 doses

      Syringe Enclosed.

      This bottle contains

      100 doses (0.3 mL/dose)

      DISTRIBUTED BY:

      DOLGENCORP, LLC

      100 MISSION RIDGE

      GOODLETTSVILLE, TN

      37072

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

      IMPORTANT: Keep this carton for future reference on full labeling
       
      Infant's Gas Relief Drop Simethicone Antigas (Image 01)

      Infant's Gas Relief Drop Simethicone Antigas (Image 01)

* Please review the disclaimer below.