Active Ingredient (In Each Tablet)
Simethicone 80 mg
Simethicone Tablet, Chewable
FDA Label NDC 71610-649
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 71610-649). 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, uses, warnings, otc - 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
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.
Otc - Keep Out Of Reach Of Children
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.
- children under 12 years: ask a doctor
Do not exceed 6 tablets in 24 hours except under the advice and supervision of 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" on one side and "137" on the other 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:
Aphena Pharma Solutions (TN)
Cookeville, TN 38506
20220519JK
Principal Display Panel - 80 Mg
NDC 71610-649 - Simethicone 80 mg Chewable Tablet - Rx Only
Bottle Label 80 mg (71610 0649 04)
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