OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each softgel)
Simethicone USP 250 mg
Simethicone Capsules USP, 250 mg
- Manufacturer
- SOFTGEL HEALTHCARE PRIVATE LIMITED
- Effective date
- 2026-10-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- daily-update
- Hydrated at
- 2026-10-13 04:05:02
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
Warnings
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 2 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 red no.33, FD&C blue no.1, gelatin, glycerin, purified water
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Products#
Every source-derived product name is available through these pages.
- Simethicone
- DIMETHICONE
- WATER
- GELATIN
- D&C RED NO. 33
- FD&C BLUE NO. 1
- GLYCERIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 35916-1940 | 35916-1940-1, 35916-1940-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIMETHICONE | 92RU3N3Y1O | ACTIB |
| WATER | 059QF0KO0R | IACT |
| GELATIN | 2G86QN327L | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2026-07-31 | daily-update | 2026-08-04 03:33:23 |
| 4 | 2026-07-18 | daily-update | 2026-07-21 05:10:26 |
| 3 | 2026-01-28 | full-release | 2026-06-01 01:35:13 |
| 2 | 2025-10-28 | monthly-update | 2026-06-03 17:39:35 |
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 |
|---|---|---|---|---|---|---|
| 57e5b6b1-0f79-5655-e063-6294a90ac944 | 322e6cb3-0ddc-9300-e063-6294a90a972a | 2026-07-31 | Warnings | 322e6cb3-0ddc-9300-e063-6294a90a972a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.