Maximum Strength Antacid Mint Tablet, Chewable
FDA Label NDC 53041-100

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 Maximum Strength Antacid Mint (NDC 53041-100). 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 125 mg

Purpose

Anti-gas

Use(S)

relieves:


  • pressure
  • bloating
  • symptoms referred to as gas

Warnings

.

Keep Out Of Reach Of Children

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately. 

Directions

  • chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
  • do not exceed 4 tablets in a 24 hour period except under the advice and supervision of 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

Maximum Strength
Antacid
Mint Flavor
Simethicone 125 mg/Anti-gas
Relieves Symptoms of Gas

60 Chewable Tablets (125 mg Ea.)

131-60-gdc.jpg (131 60 Gdc)

131-60-gdc.jpg (131 60 Gdc)

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