gc 791
5df94be7-0bc9-4be1-9982-8193e3a3c8ef
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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
Medication Information
Warnings
If pregnant or breast feeding,ask a health professional before use.
Active Ingredient
Simethicone 80 mg
Uses
relieves pressure, bloating, and fullness
commonly referred to as gas
Purpose
Anti-Gas
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.
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
Section 50565-1
Keep out of reach of children.
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
Structured Label Content
Warnings
If pregnant or breast feeding,ask a health professional before use.
Active Ingredient (Active ingredient (in each tablet))
Simethicone 80 mg
Uses
relieves pressure, bloating, and fullness
commonly referred to as gas
Purpose
Anti-Gas
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 (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.
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
Section 50565-1 (50565-1)
Keep out of reach of children.
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
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