OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each softgel)
Simethicone USP 125 mg
Simethicone Capsules USP, 125 mg
- Manufacturer
- Softgel Healthcare Pvt Ltd
- Effective date
- 2026-10-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- daily-update
- Hydrated at
- 2026-10-13 04:05:25
Label at a glance#
ProductSimethicone
Active ingredientDIMETHICONE
Label structure9 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Purpose
Antigas
INDICATIONS & USAGE SECTION
Use
for the relief of
- pressure, bloating, and fullness commonly referred to as gas
WARNINGS SECTION
Warning
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
DOSAGE & ADMINISTRATION SECTION
Directions
- adults and children 12 years and older: 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 SAFETY INFORMATION
Other information
- store at controlled room temperature 20-25ºC (68-77ºF)
- protect from light, heat, and moisture
INACTIVE INGREDIENT SECTION
Inactive ingredients
D&C yellow no.10, FD&C blue no. 1, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan solution, titanium dioxide
Principal Display Panel
Compare to Gas-X ® Extra Strength Active Ingredient*
NDC 35916-1938-2
Simethicone Capsules USP, 125 mg
Simethicone 125 mg / Antigas (Relieves Gas Fast)
Pressure, Bloating, Discomfort
30 Softgels
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
Products#
Every source-derived product name is available through these pages.
- Simethicone
- DIMETHICONE
- D&C YELLOW NO. 10
- TITANIUM DIOXIDE
- GELATIN
- PEPPERMINT OIL
- SORBITOL
- FD&C BLUE NO. 1
- GLYCERIN
- WATER
- SORBITAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 35916-1938 | 35916-1938-1, 35916-1938-2, 35916-1938-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIMETHICONE | 92RU3N3Y1O | ACTIB |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| GELATIN | 2G86QN327L | IACT |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| SORBITOL | 506T60A25R | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 4 | 2026-04-27 | full-release | 2026-06-01 01:55:04 |
| 3 | 2026-01-24 | monthly-update | 2026-06-03 17:53:13 |
| 2 | 2025-11-01 | monthly-update | 2026-06-03 17:39:50 |
| 1 | 2025-04-05 | full-release | 2026-06-01 01:15:55 |
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 |
|---|---|---|---|---|---|---|
| 5003982d-9100-ab86-e063-6394a90a83ce | 32018302-7ce5-1f15-e063-6394a90ad378 | 2026-04-27 | Warnings | 32018302-7ce5-1f15-e063-6394a90ad378 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.