Extra Strength Gas Relief Capsule, Liquid Filled
FDA Label NDC 83059-0096

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shield Pharmaceuticals Corp for the product Extra Strength Gas Relief (NDC 83059-0096). 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, active ingredient (in each softgel), purpose, uses, warnings, otc - 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

Active Ingredient (In Each Softgel)

Simethicone 125 mg

Purpose

Antigas

Uses

for the relief of

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

Warnings

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

  • adults and children 12 years and older: 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)
  • protect from light, heat, and moisture

Inactive Ingredients

FD & C blue #01, FD&C red #40,D&C yellow #10, gelatin, glycerin, peppermint oil, sorbitol solution, titanium dioxide

Questions Or Comments?

1-800-373-6981

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ValuRx
Compare to the active ingredient in Extra Strength Gas-X®

Extra Strength Gas Relief
Simethicone 125 mg

Label

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