Topcare Health Extra Strength Gas Relief Softgel Capsule, Liquid Filled
FDA Label NDC 76162-538

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Health Extra Strength Gas Relief Softgel (NDC 76162-538). 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 drug facts, active ingredient (in each softgel), purpose, uses, otc - 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

Drug Facts

Active Ingredient (In Each Softgel)

Simethicone 125 mg

Purpose

Antigas

Uses

for the relief of

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

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

ammonium hydroxide, black iron oxide, D&C Yellow No.10, FD&C Blue No.1, gelatin, glycerin, isopropyl alcohol, N-butyl alcohol, peppermint oil, propylene glycol, shellac glaze, sorbitol sorbitan solution, titanium dioxide

Questions?

Call 1-888-423-0139

Packaging

Tcgasrelief (76162538 1)

Tcgasrelief (76162538 1)

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