Ultra Strength Gas Relief
FDA Label NDC 63868-098

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc. for the product Ultra Strength Gas Relief (NDC 63868-098). 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, uses, 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 (In Each Softgel)

Simethicone 180 mg

Purpose

Anti-gas

Uses

  • relieves bloating, pressure or fullness commonly referred to as gas

Directions

  • swallow 1 or 2 softgels as needed after a meal
  • do not exceed two softgels per day except under the advice and supervision of a physician

Other Information

  • store at room temperature 59° - 86°F (15° - 30°C)

Inactive Ingredients

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

Questions Or Comments?

Call: 1-855-215-8180

Principal Display Panel

Ultra Strength Gas Relief

Simethicone 180 mg Antigas  60 Softgels

NDC 63868-098-60

*Compare to the active ingredient in PHAZYME® Ultra Strength

* Please review the disclaimer below.