Active Ingredients And Purpose
Active ingredient (in each softgel)
Simethicone 180 mg
Purpose
Antigas
ULTRA STRENGTH GAS RELIEF
- Set ID
- 28cd4c11-6ce2-4cb8-b916-d6528fb63fa9
- Manufacturer
- Spirit Pharmaceuticals LLC
- Effective date
- 2024-12-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:42:15
Key Label Information
Uses
Directions
■ adults: 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
Warnings
Warnings
Keep out of reach of children.
Directions And Dosage
Use
for the relief of ■ pressure and bloating commonly referred to as gas
Directions
■ adults: 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 Label Information
Inactive ingredients
FD&C yellow#6, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol solution, titanium dioxide
Questions or comments?
1-888-333-9792
PRINCIPAL DISPLAY PANEL
Products
- Simethicone
NDC Codes
Ingredients
| Name | UNII | Kind |
|---|---|---|
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| DIMETHICONE | 92RU3N3Y1O | ACTIB |
Complete SPL Sections
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each softgel)
Simethicone 180 mg
Purpose
Antigas
Use
for the relief of ■ pressure and bloating commonly referred to as gas
Warnings
Keep out of reach of children.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 2 softgels in 24 hours except under the advice and supervision of a physician
Other information
■ store at controlled room temperature 20-25°C (68-77°F) ■ protect from heat and moisture
Inactive ingredients
FD&C yellow#6, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol solution, titanium dioxide
Questions or comments?
1-888-333-9792
PRINCIPAL DISPLAY PANEL
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/28cd4c11-6ce2-4cb8-b916-d6528fb63fa9/290504c7-d131-ffc5-e063-6294a90a9460.xml
- XML SHA-256
- d01576097e0bf127bcc31337ec8d7efdca86fc5b492776ec1ebe88b961478555
- XML bytes
- 19366
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 290504c7-d131-ffc5-e063-6294a90a9460.xml | 2024-12-13 |
| otc | 0c02caa3-b64b-8bbe-e063-6394a90a6499.xml | 2023-12-09 |
| otc | ee8ee49e-5b66-ed5a-e053-2a95a90a5840.xml | 2022-11-30 |
| otc | cfd20db6-42e7-5d71-e053-2995a90a385f.xml | 2021-11-03 |
| otc | c11f0d97-8e5e-1dfe-e053-2a95a90a8c3e.xml | 2021-04-30 |
| otc | US GAS RELIEF.jpg | 2021-04-30 |