Firstcare Gas Relief Simethicone 125 Mg Anti-gas Tablet, Chewable
FDA Label NDC 71594-709

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Uspharma Ltd for the product Firstcare Gas Relief Simethicone 125 Mg Anti-gas (NDC 71594-709). 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, 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 Chewable)

Simethicone, 125 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 4 chewables in 24 hours except under the advice and supervision of a physician.

Other Information

  • Sodium free
  • Store at controlled room temperature 20-25°C (68-77°F).
  • Protect from light, heat and moisture.
  • Child Resistant Container; do not use if printed seal under cap is broken or missing.

Inactive Ingredients:

anhydrous citric acid, carnauba wax, corn syrup solids, croscarmellose sodium, crospovidone, glycerin, maltitol syrup, mannitol, microcrystalline cellulose, starch, sucralose, trisodium calcium phosphate.

Questions Or Comments?

Call 1-800-227-6151

Principal Display Panel-125 Mg Bottle Label

FIRSTCARE

Compare to the active 

ingredient in Gas-X®

NDC 71594-709-10

Gas Relief

SIMETHICONE 125 mg

Anti-gas

Fast Relief of:

Bloating, Pressure,
Gas discomfort

Dye-Free

Cherry Creme

100 Soft Chewables

* Please review the disclaimer below.