Indications and uses
for the relief of pressure, bloating, and fullness commonly referred to as gas
Extra Strength Gas Relief
- Manufacturer
- Shield Pharmaceuticals Corp
- Effective date
- 2026-02-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 01:47:21
Label at a glance#
ProductExtra Strength Gas Relief
Active ingredientDIMETHICONE
Label structure12 sections
Dosage and administration
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
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each softgel)
Simethicone 125 mg
Purpose
Antigas
Uses
for the relief of
- pressure, bloating, and fullness commonly referred to as gas
Warnings
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
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 information
- store at controlled room temperature 20-25ºC (68-77ºF)
- protect from light, heat, and moisture
Inactive ingredients
FD & C blue #01*, FD&C red #40, FD&C yellow #6*, FD&C yellow #10, gelatin, glycerin, peppermint oil, polyethylene glycol*, povidone*, propylene glycol*, sorbitol solution, titanium dioxide *may contain this inactive ingredient
Questions or comments?
1-800-373-6981
Additional information
Extra Strength Gas ReliefSoftgels offer fast, effective relief of pressure and bloating that antacids can’t provide. They are specially formulated with simethicone, the antigas medicine doctors recommend most for pressure, bloating, or discomfort referred to as gas. Extra Strength Gas ReliefSoftgels are concentrated to contain liquid gas-fighting medicine in a small softgels so they are easy to swallow, and there is no chalky taste. |
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
SPL UNCLASSIFIED SECTION
Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779
PRINCIPAL DISPLAY PANEL
ValuRx
Extra StrengthGas Relief
Simethicone 125 mg
Antigas
Relieves Gas Fast
- Pressure
- Bloating
- Discomfort
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIMETHICONE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83059-0118-4 | Extra Strength Gas Relief | 120 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 120 | 4 |
Products#
Every source-derived product name is available through these pages.
- Extra Strength Gas Relief
- Simethicone
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- D&C YELLOW NO. 10
- GELATIN
- GLYCERIN
- SORBITOL
- PEPPERMINT OIL
- POLYETHYLENE GLYCOL 400
- POVIDONE
- PROPYLENE GLYCOL
- TITANIUM DIOXIDE
- DIMETHICONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 83059-0118 | 83059-0118-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SORBITOL | 506T60A25R | IACT |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| DIMETHICONE | 92RU3N3Y1O | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2025-12-04 | monthly-update | 2026-06-03 17:45:21 |
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 |
|---|---|---|---|---|---|---|
| Extra Strength Gas Relief | SIMETHICONE | Shield Pharmaceuticals Corp | fafb57da-0682-475e-8ff9-17f2182129ef | 2026-02-24 | Warnings | 83059-0118-4 83059-0118 83059011804 4b965018-42bd-e0fa-e063-6394a90a0d5d fafb57da-0682-475e-8ff9-17f2182129ef |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.