Infants Gas Relief Drops
FDA Label NDC 67091-218

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Infants Gas Relief Drops (NDC 67091-218). 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, otc - keep out of reach of children, warnings, when using this product, directions, other information, 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 symptoms of gas frequently caused by air swallowing or certain formulas or foods

Otc - Keep Out Of Reach Of Children


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 immediately.

Directions

  • shake well before using
  • all dosages may be repeated as needed, after meals and at bedtime
  • fill enclosed dropper to recommend 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 under2
    		under 24
    		0.3 mL
    children over 2
    		over 24
    		0.6 mL

Other Information

store at room temperature

Inactive Ingredients

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

Questions?

1-800-824-1706 Monday - Friday 9am-4pm MST.

You may also report side effects to this phone number

Principal Display Panel

*Compare to the active ingredient in MYLICON® Non-Staining Infants Drops

Infants Gas Relief Drops

Simethicone 20 mg / Anti-Gas

Soothing Relief for: Pressure, Bloating & Gas Symptoms

Alcohol Free

Dye Free

1 fl oz (30 mL)

* Please review the disclaimer below.