Gas Relief Simethicone 250 Mg Anti-gas Tablet, Chewable
FDA Label NDC 51316-702

8 label sections · Submitted to the FDA by Cvs Pharmacy, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Gas Relief Simethicone 250 Mg Anti-gas (NDC 51316-702). 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 chewable), purpose, uses, warnings, keep out of reach of children., directions, inactive ingredients:, principal display panel-250 mg label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient (In Each Chewable)

Simethicone, 250 mg

Purpose

Antigas

Uses

for the relief of

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

Warnings

Keep Out Of Reach Of Children.

In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Directions

  • adults and children 12 years and older: take 1 or 2 chewables as needed after meals and at bedtime.
  • do not exceed 2 chewables in 24 hours except under the advice and supervision of a physician.

Inactive Ingredients:

carnauba wax, citric acid, croscarmellose sodium, crospovidone, D&C red #30 aluminum lake, flavors, glucose syrup, glycerin, gum arabic, maltitol solution,mannitol, powdered milk, propylene glycol, sorbitol, starch, sucralose, sucrose.

Principal Display Panel-250 Mg Label

CVS Health Compare to the active ingredient in Gas-X ®*

NDC 51316-702-12

Gas Relief

SIMETHICONE, 250 mg

Anti-gas

Fast Relief of:

Bloating, Pressure &
Gas discomfort


Actual Size    Mixed Berry Flavor

30 SOFT CHEWABLES

* Please review the disclaimer below.