Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each softgel) Simethicone 125 mg
OTC - PURPOSE SECTION
Purpose Anti-gas
HEB Simethicone 125 mg softgels
- Set ID
- 3f9f6560-312f-44b7-e063-6394a90a1c56
- Manufacturer
- H-E-B | TIME CAP LABS INC | MARKSANS PHARMA LIMITED
- Effective date
- 2025-12-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:31:13
Key Label Information
Uses
INDICATIONS & USAGE SECTION
Use for the relief of pressure, bloating and fullness commonly referred to as gas
Warnings
WARNINGS SECTION
Warning
Directions And Dosage
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 Label Information
INACTIVE INGREDIENT SECTION
Inactive ingredients D&C Yellow #10, FD&C blue 1, FD&C red #40, gelatin, glycerol, medium chain triglyceride, peppermint oil, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments? Call 1-877-290-4008
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
722T SImethicone 125mg softgels 30ct 722T Simethicone 125mg softgels 200ct
Products
- Gas Relief
- Simethicone
NDC Codes
Ingredients
| Name | UNII | Kind |
|---|---|---|
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| DIMETHICONE | 92RU3N3Y1O | ACTIB |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | IACT |
| SHELLAC | 46N107B71O | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
Complete SPL Sections
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each softgel) Simethicone 125 mg
OTC - PURPOSE SECTION
Purpose Anti-gas
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 room temperature protect from light, heat and moisture
INACTIVE INGREDIENT SECTION
Inactive ingredients D&C Yellow #10, FD&C blue 1, FD&C red #40, gelatin, glycerol, medium chain triglyceride, peppermint oil, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments? Call 1-877-290-4008
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
722T SImethicone 125mg softgels 30ct 722T Simethicone 125mg softgels 200ct
Source Document
Official SPL XML cached by FDA.report ยท DailyMed PDF
- XML object
- dailymed/3f9f6560-312f-44b7-e063-6394a90a1c56/46ad2019-efba-c0e8-e063-6294a90a46e6.xml
- XML SHA-256
- d06a573804b1de37c8a2d02f771c4d41bb5470f3f3f147767015400d6235734f
- XML bytes
- 24848
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 46ad2019-efba-c0e8-e063-6294a90a46e6.xml | 2026-01-06 |
| otc | HEB 722T 200ct.jpg | 2026-01-06 |
| otc | HEB 722T 30ct.jpg | 2026-01-06 |