Extra Strength Gas Relief
FDA Label NDC 33992-3113

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Greenbrier International, Inc. for the product Extra Strength Gas Relief (NDC 33992-3113). 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 (per 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 (Per Each Softgel)

Simethicone 125 mg

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 room temperature
  • 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, titanium dioxide

Questions Or Comments

1-866-467-2748

Principal Display Panel

Extra Strength Gas Relief Simeticone ,125 mg Anti-gas 15 Softgels (925a95c3 Fa9f 453d 97c7 4c5563da0067 01)

Extra Strength Gas Relief Simeticone ,125 mg Anti-gas 15 Softgels (925a95c3 Fa9f 453d 97c7 4c5563da0067 01)

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

Assured

Extra Strength

Gas Relief

SIMETHICONE, 125mg

ANTI-GAS

Relieves:

  • Bloating
  • Pressure
  • Fullness
  • Gas

    15 SOFTGELS

    • *This product is not manufactured or distributed by GSK Consumer Healthcare, Inc., the distributor of Gas-X® Extra strength.

    Distributed by:

    Greenbrier International, Inc.

    Chesapeake, VA 23320

    IMPORTANT: Keep this carton for future reference on full labeling.

    DO NOT USE IF ANY INDIVIDUAL BLISTER IS BROKEN OR OPEN

* Please review the disclaimer below.