Indications and uses
for the relief of pressure, bloating, and fullness commonly referred to as gas
for the relief of pressure, bloating, and fullness commonly referred to as gas
• chew thoroughly • 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
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)
Simethicone 80 mg
Anti-Gas
for the relief of
If pregnant or breast feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
• chew thoroughly
• 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
dextrose, sugar, maltodextrin, microcrystalline cellulose, peppermint flavor, silica, sorbitol, stearic acid
1-800-540-3765
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57896-799-01 | 2022-12-15 | C162847 | 48780-1 | d6a99b39-ce33-a426-e053-dadaa90af4c2 | gc 791a (799) |
| 57896-799-08 | 2022-12-15 | C162847 | 48780-1 | d6a99b39-ce33-a426-e053-dadaa90af4c2 | gc 791a (799) |
| 57896-799-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ce33-a426-e053-dadaa90af4c2 | gc 791a (799) |
| 57896-799-08 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ce33-a426-e053-dadaa90af4c2 | gc 791a (799) |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57896-799-01 | EA - Each | 57896-799 | a4b10310-54df-455c-a2da-6bb896ac436c | 1 | 2021-03-02 |
| 57896-799-08 | EA - Each | 57896-799 | a719d384-226d-4303-9d1b-b9b42aa318d8 | 1 | 2021-01-08 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 57896-799 | 57896-799-01, 57896-799-08 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROSE | IY9XDZ35W2 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| SORBITOL | 506T60A25R | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| DIMETHICONE | 92RU3N3Y1O | ACTIB |
| SUCROSE | C151H8M554 | IACT |
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 |
|---|---|---|---|---|---|---|
| 45756704-0062-5ac1-e063-6294a90a6734 | b66f63d0-be82-a75b-e053-2a95a90a3f13 | 2025-12-08 | Warnings | b66f63d0-be82-a75b-e053-2a95a90a3f13 |
Adverse event summaries are temporarily unavailable. Other product information remains available.