Simethicone
FDA Label NDC 68210-4091

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Simethicone (NDC 68210-4091). 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 softgel), purpose, use, directions, other information, inactive ingredients, questions or comments?, 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 Softgel)

Simethicone 125mg

Purpose

Antigas

Use

for the relief of

  • pressure, bloating, and fullness commonly referred to as gas

Directions

  • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other Information

  • store at controlled room temperature 20-25°C (68-77°F)
  • protect from light, heat, and moisture

Inactive Ingredients

 FD&C blue 1, FD&C yello#10, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan, titanium dioxide

Questions Or Comments?

1-888-333-9792

Principal Display Panel

Compare to the active ingredient
in Extra Strength Gas-X®†

Extra Strength Gas Relief

SIMETHICONE 125 MG / ANTIGAS

†This product is not manufactured or distributed by GlaxoSmithKline,
owner of the registered trademark Extra Strength Gas-X®

* Please review the disclaimer below.