Simethicone Tablet, Chewable
FDA Label NDC 71610-607

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 Simethicone (NDC 71610-607). 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 drug facts, active ingredient, purpose, uses, warnings, 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

Drug Facts

.

Active Ingredient

(in each chewable tablet)

Simethicone 80 mg

Purpose

Antiflatulent

Uses

relieves

  • bloating
  • pressure
  • discomfort of gas which can be caused by certain foods or air swallowing

Warnings

If pregnant or breast-feeding, ask a health professional before use.

Directions

  • chew thoroughly 1 to 2 tablets as needed after meals and at bed time.
  • do not exceed 6 tablets per day unless directed by a doctor

Other Information

  • store at room temperature 15-30 °C (59-86 °F)
  • protect from moisture

Inactive Ingredients

dextrose, dipac sugar, maltodextrin, peppermint flavor, sorbitol, stearic acid

Questions Or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Call 804-270-4498, 8.30 am – 4.30 pm EST Monday - Friday

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
471610-607-04

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

20211105JH

Principal Display Panel - 80 Mg

NDC 71610-607 - Simethicone 80 mg Chewable Tablets

Bottle Label 80 mg (71610 0607 04)

Bottle Label 80 mg (71610 0607 04)

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