Dosage and administration
adults: chew 1 or 2 tablets as needed after meals and at bedtime do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician
EXTRA STRENGTH GAS RELIEF
- Manufacturer
- Geri-Care Pharmaceuticals, Corp
- Effective date
- 2020-12-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:00:40
Label at a glance#
ProductEXTRA STRENGTH GAS RELIEF
Active ingredientDIMETHICONE
Label structure8 sections
Storage and handling
each tablet contains: calcium 89 mg Tamper Evident: Do not use if imprinted seal under cap is missing or broken. store at controlled room temperature protect from moisture
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Simethicone 125 mg
Purpose
Antigas
Use
for the relief of 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. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- adults: chew 1 or 2 tablets as needed after meals and at bedtime
- do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician
Other information
- each tablet contains: calcium 89 mg
- Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
- store at controlled room temperature
- protect from moisture
Inactive ingredients
cherry flavor, D&C red #27 lake, D&C red #30 lake, dextrates, FD&C red #40 lake, silica gel, sorbitol, starch, stearic acid, talc, tri-calcium phosphate
package label
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57896-691-03 | 2020-12-22 | C162847 | 48780-1 | 9d75b9d0-c793-f424-e053-dadaa90a57ce | GC691 |
| 57896-691-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c793-f424-e053-dadaa90a57ce | GC691 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57896-691-03 | EA - Each | 57896-691 | 730f3bf1-96e8-4832-986d-7a1f045aadc1 | 1 | 2018-01-12 |
Products#
Every source-derived product name is available through these pages.
- EXTRA STRENGTH GAS RELIEF
- Simethicone
- TALC
- TRICALCIUM PHOSPHATE
- SORBITOL
- SILICON DIOXIDE
- STEARIC ACID
- DIMETHICONE
- DEXTRATES
- D&C RED NO. 27
- D&C RED NO. 30
- FD&C RED NO. 40
- STARCH, CORN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 57896-691 | 57896-691-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TALC | 7SEV7J4R1U | IACT |
| TRICALCIUM PHOSPHATE | K4C08XP666 | IACT |
| SORBITOL | 506T60A25R | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| DIMETHICONE | 92RU3N3Y1O | ACTIB |
| DEXTRATES | G263MI44RU | IACT |
| D&C RED NO. 27 | 2LRS185U6K | IACT |
| D&C RED NO. 30 | 2S42T2808B | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
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 |
|---|---|---|---|---|---|---|
| d22f319d-c2c6-3d99-e053-2a95a90a6d23 | 612d55f3-54b0-488c-e053-2991aa0ae025 | 2021-12-02 | Warnings | 612d55f3-54b0-488c-e053-2991aa0ae025 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.