Gas Relief Tablet, Chewable
FDA Label NDC 53041-103

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Guardian Drug Company for the product Gas Relief (NDC 53041-103). 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 tablet), purpose, use(s), warnings, 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 Tablet)

Simethicone 80 mg

Purpose

Antigas

Use(S)

relieves:


  • pressure
  • bloating
  • symptoms referred to as gas

Warnings

.

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center immediately. 

Directions

  • chew 2 to 4 tablets thoroughly as needed after meals and at bedtime
  • do not exceed 6 tablets per day unless directed by a physician

Other Information

  • do  not use if inner seal is broken
  • store at room temperature
  • avoid high humidity and excessive heat, above 40oC (104oF)

Inactive Ingredients

compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.

Principal Display Panel

GUARDIAN 

NDC 53041-103-16


*Compare to the Active Ingredient in MYLANTA® GAS

MINT FLAVOR

GAS BAN


ANTI-GAS/
SIMETHICONE

80 mg

Provides Fast Relief of

Pressure, Bloating

& Gas Distress

100 Chewable Tablets (80 mg Ea.)

103-100-gdc.jpg (103 100 Gdc)

103-100-gdc.jpg (103 100 Gdc)

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