FDA Label for Extra Strength Gas Relief

View Indications, Usage & Precautions

Extra Strength Gas Relief Product Label

The following document was submitted to the FDA by the labeler of this product Greenbrier International, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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



*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.