Gas Relief Simethicone 125mg Softgel Capsule, Liquid Filled
FDA Label NDC 84324-014

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nuvicare Llc for the product Gas Relief Simethicone 125mg Softgel (NDC 84324-014). 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 softgel), purpose, use, warnings, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Softgel)

Simethicone 125 mg

Purpose

Antigas

Use

Use for the relief of pressure, bloating, and fullness, commonly referred to as gas.

Warnings

If pregnant or breast-feeding, ask a health professional before use.

Directions

  • adults: 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 15° to 30°C (59° to 86°F)
  • protect from light, heat, and moisture

Inactive Ingredients

Peppermint Oil, Gelatin, Sorbitol,  Sorbitan Anhydrous, Glycerin, FD & C blue 1 (Brilliant Blue FCF), Titanium Dioxide, D & C Yellow 10 (Quinoline Yellow).

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