FDA Label for Simethicone 125mg Gas Relief

View Indications, Usage & Precautions

Simethicone 125mg Gas Relief Product Label

The following document was submitted to the FDA by the labeler of this product One2zee Limited Liability Company. 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.

Drug Facts




Otc - Active Ingredient



Active Ingredients (in each softgel)

Simethicone 125 mg


Otc - Purpose



Purpose

Antigas


Indications & Usage



Use for the relief of

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

Warning




Keep Out Of Reach Of Children




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)
  • protact from light, heat and moisture
  • do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredient



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


Otc - Questions



Questions or comments?
Call 1-833-663-2933


* Please review the disclaimer below.