Dosage and administration
adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
Simethicone
- Manufacturer
- SPIRIT PHARMACEUTICALS LLC
- Effective date
- 2024-12-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-06-01 00:42:26
Label at a glance#
ProductSimethicone
Active ingredientDIMETHICONE
Label structure9 sections
Storage and handling
store at controlled room temperature 20-25ºC (68-77ºF) protect from light, heat, and moisture
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each softgel)
Simethicone 125mg
Purpose
Antigas
Use
for the relief of
- pressure, bloating, and fullness commonly referred to as gas
Warning
Keep out of reach of children.
Directions
- adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
- do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
Other information
- store at controlled room temperature 20-25ºC (68-77ºF)
- protect from light, heat, and moisture
Inactive ingredients
FD&C blue 1, FD&C yello#10, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan, titanium dioxide
Questions or comments?
1-888-333-9792
PRINCIPAL DISPLAY PANEL
Compare to the active ingredient
in Extra Strength Gas-X®†
Extra Strength Gas Relief
SIMETHICONE 125 MG / ANTIGAS
†This product is not manufactured or distributed by GlaxoSmithKline,
owner of the registered trademark Extra Strength Gas-X®
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 |
|---|---|---|---|---|---|---|
| 68210-4091-1 | Simethicone | 75 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 75 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68210-4091 | SIMETHICONE CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC] | 7 | Legacy NDC, 1 package rows | 20241213_503b42db-026a-4b0f-90cb-1ea0765c6e84.zip |
Products#
Every source-derived product name is available through these pages.
- Simethicone
- D&C YELLOW NO. 10
- FD&C BLUE NO. 1
- GELATIN
- GLYCERIN
- PEPPERMINT OIL
- SORBITAN
- SORBITOL
- TITANIUM DIOXIDE
- WATER
- DIMETHICONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68210-4091 | 68210-4091-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| SORBITOL | 506T60A25R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| 2904da06-b747-e3db-e063-6394a90a7d79 | 503b42db-026a-4b0f-90cb-1ea0765c6e84 | 2024-12-11 | Warnings | 2904da06-b747-e3db-e063-6394a90a7d79 503b42db-026a-4b0f-90cb-1ea0765c6e84 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.