Leader Gas Relief Tablet, Chewable
FDA Label NDC 70000-0434

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Leader Gas Relief (NDC 70000-0434). 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

NDC 70000-0434-1
LEADER™
Gas Relief

Simethicone, 80 mg
Antigas
Mint Flavor

For Relief of :
Pressure, Bloating, Symptoms Referred to as Gas

100 CHEWABLE TABLETS



103 (103)

103 (103)

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