Walgreens Infants Dye Free Gas Relief Emulsion
FDA Label NDC 0363-0790

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Walgreens Infants Dye Free Gas Relief (NDC 0363-0790). 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 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 (towards inner cheek)
  • all dosages may be repeated 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, 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

Walgreens

Compare to infant’s Mylicon Gas Relief active ingredient††

Infants'

Dye- Free

Gas Relief

Simethicone 20 mg PER DOSE /ANTI-GAS

  •  DYE FREE
  •  NONSTAINING FORMULA
  •  ALCOHOL FREE
    • No saccharin
    • No artificial flavor
    • Includes dosing syringe

      • 100 DOSES DYE FREE

      1 FL OZ (30 mL)

      200 WILMOT RD., DEERFIELD, IL 60015

      100% SATISFACTION GUARANTEED

      Walgreens.com ©2017 Walgreen Co,

      WALGREENS PHARMACIST RECOMMENDED‡

      ‡Walgreens Pharmacist Survey

      ‡‡ This product is not manufactured or distributed by infirst Healthcare Inc., the distributor of Infants’ Mylicon® Gas Relief.

      IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING
       
      Infants' Dye-free Gas Relief Simethicone 20 mg Per Dose /anti Gas 100 Doses 1 Fl Oz (30 mL) (Image 01)

      Infants' Dye-free Gas Relief Simethicone 20 mg Per Dose /anti Gas 100 Doses 1 Fl Oz (30 mL) (Image 01)

* Please review the disclaimer below.