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SIMETHICONE

Dosage form
TABLET, CHEWABLE
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Label updated
2025-01-10
Retrieved
2026-09-07
Active ingredients
DIMETHICONE
View original label and images on DailyMed ↗
Active ingredient (in each tablet)

Simethicone 80 mg

Purpose

Anti-Gas

Uses

relieves pressure, bloating, and fullness
commonly referred to as gas

Warnings

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

Label information

Keep out of reach of children.

Directions
  • chew or crush tablet completely before swallowing
  • adults and children 12 years and over: take 1-2 tablets as needed after meals and at bedtime.

Do not exceed 6 tablets in 24 hours except under the advice and supervision of a doctor.

  • children under 12 years: ask a doctor
Other information
  • each tablet contains: calcium 65 mg
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken
  • store at room temperature, 15°C - 30°C (59˚F - 86˚F)
  • protect from moisture
HOW SUPPLIED

Simethicone Chewable Tablets, 80 mg are white, round, tablets, debossed with "44 & 137" on one side and are supplied as:

NDC 57896-791-01 in bottle of 100 chewable tablets

NDC 57896-791-08 in bottle of 80 chewable tablets

Distributed by:

GERI-CARE Pharmaceuticals Corp.

1650 63rd Street, Brooklyn, NY 11204

Inactive ingredients

cellulose, corn starch, crospovidone, dextrates hydrated, flavor,
magnesium stearate, silica, sucralose, calcium phosphate.

Questions or comments?

1-800-540-3765

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:

Count 80 mg
4 71610-649-04

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:

[Image in the official label — see DailyMed source]


Cookeville, TN 38506

20220519JK

PRINCIPAL DISPLAY PANEL - 80 mg

NDC 71610-649 - Simethicone 80 mg Chewable Tablet - Rx Only

[Image in the official label — see DailyMed source]

DailyMed Set ID: 5df94be7-0bc9-4be1-9982-8193e3a3c8ef · Version 3
NDC: 71610-649