Antiflatulent Tablet, Chewable
FDA Label NDC 0904-7206

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Antiflatulent (NDC 0904-7206). 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 (1-800-222-1222) 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.

Questions

Call (800) 616-2471

Principal Display Panel

NDC 0904-7206-60
MAJOR
Simethicone 80 mg

Antiflatulent

Relieves gas pain, pressure and bloating
 
100 Chewable Tablets


98 (103 Maj)

98 (103 Maj)



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