Gas Relief Tablet, Chewable
FDA Label NDC 21130-135

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safeway for the product Gas Relief (NDC 21130-135). 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 tablet), purpose, uses, warnings, directions, other information, inactive ingredients, pdp, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Simethicone 125 mg

Purpose

Anti-gas

Uses

relieves:

  • pressure
  • bloating
  • symptoms referred to as gas

Warnings

Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center immediately.

Directions

  • chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
  • do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician

Other Information

  • do not use if any individual blister unit is broken or open
  • store at room temperature
  • avoid high humidity and excessive heat, above 40oC (104oF)

Inactive Ingredients

D&C red 30 aluminum lake, D&C yellow 10 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

Pdp

*Compare to GAS-X®E-X Chewable active ingredient

Signature Care

Extra strength Gas Relief

Simethicone 125 mg

Anti-Gas

Peppermint Flavor

Relieves symptoms of gas discomfort, pressure and bloating

18 chewable tablets

Box (134pptleo)

Box (134pptleo)

* Please review the disclaimer below.