Infants Gas Relief Drops Emulsion
FDA Label NDC 49035-709

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores,inc., for the product Infants Gas Relief Drops (NDC 49035-709). 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?, 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.
  • 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.
  • fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
  • clean dropper well after each use-recap bottle with original cap
  • 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, microcrystalline cellulose, natural flavors, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum.

Questions?

1-866-467-2748

Principal Display Panel

Compare to active ingredient in infant’s Mylicon Drops*

Infants'

Gas Relief

Drops

Simethicone 20 mg /Antigas

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

      • 1 FL. OZ. (30 mL) 100 doses

      Distributed by:

      * 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
       
      Equate Infants' Gas Relief Drops 1 Fl. Oz.(30 mL) 100 Doses (Image 01)

      Equate Infants' Gas Relief Drops 1 Fl. Oz.(30 mL) 100 Doses (Image 01)

* Please review the disclaimer below.