Gas-x Capsule, Liquid Filled
FDA Label NDC 0067-6275

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Gas-x (NDC 0067-6275). 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, purpose, use, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

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 20-25o C (68-77o F)
  • Protect from light, heat, and moisture

Inactive Ingredients

D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, hypromellose, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

Questions Or Comments?

call 1-800-452-0051

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