Gc 791
5df94be7-0bc9-4be1-9982-8193e3a3c8ef
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Simethicone 80 mg
Purpose
Anti-Gas
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
Medication Information
Purpose
Anti-Gas
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
Description
Simethicone 80 mg
Uses
relieves pressure, bloating, and fullness
commonly referred to as gas
Section 50565-1
Keep out of reach of children.
Warnings
If pregnant or breast feeding,ask a health professional before use.
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
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:
Cookeville, TN 38506
20220519JK
Principal Display Panel 80 Mg
NDC 71610-649 - Simethicone 80 mg Chewable Tablet - Rx Only
Active Ingredient (in Each Tablet)
Simethicone 80 mg
Structured Label Content
Uses
relieves pressure, bloating, and fullness
commonly referred to as gas
Section 50565-1 (50565-1)
Keep out of reach of children.
Purpose
Anti-Gas
Warnings
If pregnant or breast feeding,ask a health professional before use.
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
How Supplied (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
Other Information (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
Inactive Ingredients (Inactive ingredients)
cellulose, corn starch, crospovidone, dextrates hydrated, flavor,
magnesium stearate, silica, sucralose, calcium phosphate.
Questions Or Comments? (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:
Cookeville, TN 38506
20220519JK
Principal Display Panel 80 Mg (PRINCIPAL DISPLAY PANEL - 80 mg)
NDC 71610-649 - Simethicone 80 mg Chewable Tablet - Rx Only
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))
Simethicone 80 mg
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:18.465795 · Updated: 2026-03-14T23:06:55.199519