Indications and uses
relieves pressure, bloating, and fullness commonly referred to as gas
SIMETHICONE
- Manufacturer
- Aphena Pharma Solutions - Tennessee, LLC
- Effective date
- 2025-01-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:52:07
Label at a glance#
ProductSIMETHICONE
Active ingredientDIMETHICONE
Label structure11 sections
Dosage and administration
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
Storage and handling
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
Contacts and useful links#
Label contents#
Full prescribing information#
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 Suppliedsection 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
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIMETHICONE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71610-649-04 | SIMETHICONE | 4 in 1 BOTTLE | TABLET, CHEWABLE | 4 | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71610-649-04 | EA - Each | 71610-649 | 04bb6eb4-a32a-46dd-8262-47bc96868434 | 1 | 2022-07-06 |
| 57896-791-01 | EA - Each | 57896-791 | d7abb991-f273-4ad8-8ac3-e1239c002ec0 | 1 | 2014-12-01 |
| 57896-791-08 | EA - Each | 57896-791 | c9e325d9-2782-4318-861b-0e093f6d3dfd | 1 | 2022-02-07 |
Products#
Every source-derived product name is available through these pages.
- SIMETHICONE
- CELLULOSE, MICROCRYSTALLINE
- DEXTRATES
- SILICON DIOXIDE
- TRICALCIUM PHOSPHATE
- STARCH, CORN
- CROSPOVIDONE
- MAGNESIUM STEARATE
- SUCRALOSE
- DIMETHICONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71610-649 | 71610-649-04 |
| 57896-791 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| DEXTRATES | G263MI44RU | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| TRICALCIUM PHOSPHATE | K4C08XP666 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| CROSPOVIDONE | 2S7830E561 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| DIMETHICONE | 92RU3N3Y1O | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| SIMETHICONE | SIMETHICONE | Geri-Care Pharmaceuticals, Corp | be96ce05-dd74-4915-9a8f-2a1b34e2f158 | 2025-11-17 | Warnings | 57896-791 |
| SIMETHICONE | SIMETHICONE | Aphena Pharma Solutions - Tennessee, LLC | 5df94be7-0bc9-4be1-9982-8193e3a3c8ef | 2025-01-10 | Warnings | 71610-649-04 71610-649 71610064904 2b5afc84-182d-07ef-e063-6294a90a9f3e 5df94be7-0bc9-4be1-9982-8193e3a3c8ef |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.