SIMETHICONE
- Dosage form
- TABLET, CHEWABLE
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Label updated
- 2025-01-10
- Retrieved
- 2026-09-07
- Active ingredients
- DIMETHICONE
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