Gas Relief Simethicone 180mg Softgel Capsule, Liquid Filled
FDA Label NDC 84324-015

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 180mg Softgel (NDC 84324-015). 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, uses, 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 180 mg

Purpose

Antiflatulent (Antigas)

Uses

relieves

  • bloating
  • pressure
  • fullness commonly referred to as gas

Warnings

Stop use and ask a doctor if condition persists.

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

Directions

  • swallow one or two softgels as needed after a meal
  • do not exceed two softgels per day except under the advice and supervision of a physician

Other Information

  • store at 15° to 30°C (59° to 86°F)

Inactive Ingredients

Peppermint oil, Gelatin, Sorbitol, sorbitan anhydrous, Glycerin, Titanium dioxide, FD &C yellow 6/sunset yellow, Black iron oxide.

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