Simethicone 125mg Gas Relief
FDA Label NDC 55629-021

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by One2zee Limited Liability Company for the product Simethicone 125mg Gas Relief (NDC 55629-021). 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 drug facts, otc - active ingredient, otc - purpose, indications & usage, warning, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.