Active Ingredients And Purpose
Active ingredient (in each softgel)
Simethicone 125mg
Purpose
Antigas
Extra Strength Gas Relief
- Set ID
- 503b42db-026a-4b0f-90cb-1ea0765c6e84
- 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
Key Label Information
Uses
Use
for the relief of pressure, bloating, and fullness commonly referred to as gas
Warnings
Warning
Directions And Dosage
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 Label Information
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®
Products
- Simethicone
NDC Codes
Ingredients
| 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 |
Complete SPL Sections
Active ingredient (in each softgel)
Simethicone 125mg
Purpose
Antigas
Use
for the relief of pressure, bloating, and fullness commonly referred to as gas
Warning
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®
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/503b42db-026a-4b0f-90cb-1ea0765c6e84/2904da06-b747-e3db-e063-6394a90a7d79.xml
- XML SHA-256
- d963bac0d06176c569f47db6996275cd4eceebabe2a6b968765376f14c9bcfde
- XML bytes
- 18283
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 2904da06-b747-e3db-e063-6394a90a7d79.xml | 2024-12-13 |
| otc | 0bf2d31c-2709-0b42-e063-6394a90a7d8a.xml | 2023-12-08 |
| otc | eec8df20-15c5-8ee3-e053-2995a90ae339.xml | 2022-12-02 |
| otc | d2067606-c61b-fa0c-e053-2a95a90ab648.xml | 2021-12-01 |
| otc | a978b536-2a21-a6af-e053-2995a90a8406.xml | 2020-07-03 |
| otc | gr 75 CT.jpg | 2020-07-03 |