Gas Relief Tablet, Chewable
FDA Label NDC 62011-0189

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Gas Relief (NDC 62011-0189). 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, otc - keep out of reach of children, warnings, directions, other information, inactive ingredients, 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

Otc - Keep Out Of Reach Of Children


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 and C red 30 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

Principal Display Panel

compare to Gas-X Extra strength chewable tablets active ingredient

gas relief

simethicone 125 mg

soothing relief for pressure, bloating and gas symptoms

cherry creme flavor

extra strength

18 chewable tablets

* Please review the disclaimer below.