Gas Relief
FDA Label NDC 51013-430

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Puracap Pharmaceutical Llc for the product Gas Relief (NDC 51013-430). 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)

→ Purpose

→ Uses

→ Warnings

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredient (In Each Softgel)

Simethicone 125 mg

Purpose

Antigas

Uses

for the relief of

pressure, bloating, and fullness commonly referred to as gas

Warnings

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