Ultra Strength Gas Relief Capsule, Liquid Filled
FDA Label NDC 49035-585

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores Inc for the product Ultra Strength Gas Relief (NDC 49035-585). 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, use, 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.

Active Ingredient (In Each Softgel)

Simethicone 180 mg

Purpose

Antigas

Use

 for the relief of

  • pressure and bloating 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 2 softgels in 24 hours under the advice and supervision of a physician

Other Information

  • store at controlled room temperature 15° - 30°C (59° - 86°F)
  • protect from heat and moisture
  • do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

FD&C yellow#6, gelatin, glycerin, purified water and white ink

Questions Or Comments?

Call toll free: 1-888-287-1915

Principal Display Panel

Ultra Strength Gas Relief

Simethicone 180 mg Anti-gas  50 Softgels

NDC 49035-585-21

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

Wm21-00-front (Wm21 00 Front)

Wm21-00-front (Wm21 00 Front)

Wm21-00-back (Wm21 00 Back)

Wm21-00-back (Wm21 00 Back)

* Please review the disclaimer below.