Antiflatulent Tablet, Chewable
FDA Label NDC 71610-650

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aphena Pharma Solutions - Tennessee, Llc for the product Antiflatulent (NDC 71610-650). 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, how supplied, 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)

How Supplied

Simethicone Chewable Tablets, 80 mg are white, round, tablets, debossed with "G" on one side and "103" on the other side and are supplied as:

NDC 0904-7206-60 in bottle of 100 chewable tablets

Distributed by:

Major Pharmaceuticals

Livonia, MI 48152

Inactive Ingredients

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

Questions

Call (800) 616-2471

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count80 mg
471610-650-04

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Aphena Pharma Solutions (TN)

Aphena Pharma Solutions (TN)


Cookeville, TN 38506

20220519JK

Principal Display Panel - 80 Mg

NDC 71610-650 - Simethicone 80 mg Chewable Tablet - Rx Only

Bottle Label 80 mg (71610 0650 04)

Bottle Label 80 mg (71610 0650 04)

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