Infants Non-staining Gas Relief Solution/ Drops
FDA Label NDC 37808-014

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H E B for the product Infants Non-staining Gas Relief (NDC 37808-014). 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, use(s), warnings, keep out of reach of children, directions, other information, inactive ingredient section, 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

Use(S)

relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods


Warnings

When using this product do not exceed 12 doses per day

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
  • all dosages may be repeated as needed, after meals and at bedtime 
  • fill enclosed dropper to recommended dosage level
  • dispense liquid slowly into baby's mouth, toward the inner cheek
  • may mix with 1 oz. of cool water, infant formula or other suitable liquids
  • clean dropper after each use and close the bottle to maintain child resistance

    •  age (yr)weight (lb)dose
     infants under 2 under 240.3 mL
     children over 2over 240.6 mL

Other Information

store at room temperature

Inactive Ingredient Section

benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum

Principal Display Panel

Compare to Infants' Mylicon® Drops Non-Staining active ingredient*

NDC 37808-014-09


HEB

Infants' Non-Staining

Gas Relief

Drops

simethicone 20 mg 

Anti-Gas


  • Fast Relief of Gas Symptoms
  • No Artificial flavor
  • Gentle & Safe**
  • Alcohol Free
  • Dye free

    • **Use only as directed, do not exceed more than 12 doses per day.


    1 FL OZ (30 mL)

    107 (520)

    107 (520)

* Please review the disclaimer below.