Extra Strength Gas Relief Capsule, Liquid Filled
FDA Label NDC 83059-0118

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 83059-0118). 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 other, 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.

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Drug Facts

Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779

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, FD&C yellow #6*, FD&C yellow #10, gelatin, glycerin, peppermint oil, polyethylene glycol*, povidone*, propylene glycol*, sorbitol solution, titanium dioxide *may contain this inactive ingredient

Questions Or Comments?

1-800-373-6981

Additional Information

Extra Strength Gas ReliefSoftgels offer fast, effective relief of pressure and bloating that antacids can’t provide. They are specially formulated with simethicone, the antigas medicine doctors recommend most for pressure, bloating, or discomfort referred to as gas.

Extra Strength Gas ReliefSoftgels are concentrated to contain liquid gas-fighting medicine in a small softgels so they are easy to swallow, and there is no chalky taste.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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ValuRx

Extra StrengthGas Relief

Simethicone 125 mg
Antigas

Relieves Gas Fast

  • Pressure
  • Bloating
  • Discomfort

* Please review the disclaimer below.