Gas Relief Capsule, Liquid Filled
FDA Label NDC 80513-112

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Llc for the product Gas Relief (NDC 80513-112). 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, use, otc - ask doctor, otc - keep out of reach of children, directions, other information, 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 250 mg

Purpose

Antigas

Use

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

Otc - Ask Doctor

Stop use and ask a doctor if condition persists

Otc - Keep Out Of Reach Of Children

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

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 2 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
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive Ingredients

D&C red #33, FD&C blue #1, gelatin, glycerin, purified water and white edible ink.

Questions?

call 1-800-630-8895

Other

Distributed by:

Advanced Rx LLC

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A.

Package Label.Principal Display Panel

NDC 80513-112-01

Compare to the active ingredient in Maximum Strength Gas-X ®†

HIGH POTENCY

GAS RELIEF

Simethicone 250 mg

• RELIEVES GAS FAST

• PRESSURE

• BLOATING

• DISCOMFORT

100 SOFTGELS

†This product is not manufactured or distributed by the owner of the registered trademark Maximum Strength Gas-X ®

Carton (Label 250mg)

Carton (Label 250mg)

* Please review the disclaimer below.