Dosage and administration
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
Gas Relief
- Manufacturer
- Advanced Rx LLC | ELYSIUM PHARMACEUTICALS LIMITED
- Effective date
- 2025-01-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:52:53
Label at a glance#
ProductGas Relief
Active ingredientDIMETHICONE
Label structure10 sections
Storage and handling
store at 20° to 25°C (68° to 77°F) protect from light, heat and moisture DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients (in each softgel)
Simethicone 125 mg
OTC - PURPOSE SECTION
Purpose
Antigas
INDICATIONS & USAGE SECTION
Usefor the relief of pressure, bloating, fullness, commonly referred to as gas.
Warning
If pregnant or breast-feeding,ask a health professional before use.
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 4 softgels in 24 hours except under the advice and supervision of a physician
Other Information
- store at 20° to 25°C (68° to 77°F)
- protect from light, heat and moisture
- DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
INACTIVE INGREDIENT SECTION
D&C Yellow 10, FD&C Blue 1, Edible Ink, Gelatin, Glycerin, Peppermint oil, POLYSORB, Purified water, Titanium dioxide.
OTC - QUESTIONS SECTION
Questions?
call
1-800-630-8895
SPL UNCLASSIFIED SECTION
Distributed by:
Advanced Rx LLC
1942 NE 163rd St North Miami Beach,
FL 33162 U.S.A.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 80513-117-12
Extra Strength
GAS RELIEF
Simethicone 125 mg
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 |
|---|---|---|---|---|---|---|
| 80513-117-12 | Gas Relief | 120 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 120 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Gas Relief
- Simethicone
- D&C YELLOW NO. 10
- FD&C BLUE NO. 1
- GELATIN
- GLYCERIN
- PEPPERMINT OIL
- WATER
- TITANIUM DIOXIDE
- DIMETHICONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 80513-117 | 80513-117-12 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| 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 |
| WATER | 059QF0KO0R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| DIMETHICONE | 92RU3N3Y1O | ACTIB |
Source Document#
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 |
|---|---|---|---|---|---|---|
| Gas Relief | SIMETHICONE | Advanced Rx LLC | 5dcd50ae-370d-4e49-b981-db42b86c2ecb | 2025-01-01 | Warnings | 80513-117-12 80513-117 80513011712 2bd59ae1-05d2-f803-e063-6394a90adb88 5dcd50ae-370d-4e49-b981-db42b86c2ecb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.