Gas Relief
FDA Label NDC 51013-109

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Puracap Pharmaceutical Llc for the product Gas Relief (NDC 51013-109). 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, uses, warnings, 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 (In Each Softgel)

Simethicone 125 mg

Purpose

Antigas

Uses

for the relief of

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

Warnings

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 room temperature 15°-30°C (59°-86°F)
  • protect from light, heat and moisture

Inactive Ingredients

D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, white edible ink

Questions Or Comments?

Call toll free: 1-800-833-6278

Principal Display Panel

EXTRA STRENGTH GAS RELIEF 

SIMETHICONE 125 mg ANTIGAS 30 Softgels

NDC 51013-109-10

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

EXTRA STRENGTH GAS RELIEF 

SIMETHICONE 125 mg ANTIGAS 50 Softgels

NDC 51013-109-09

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

* Please review the disclaimer below.