Gas Relief Capsule, Liquid Filled
FDA Label NDC 73581-301

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Yyba Corp for the product Gas Relief (NDC 73581-301). 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, 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

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

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


Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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 20° to 25°C (68° to 77°F)

■ protect from light, heat and moisture

Inactive Ingredients

FD&C blue #1, FD&C yellow #10, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol 70% solution, titanium dioxide.

Questions?

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