Indications and uses
for the relief of pressure, bloating, and fullness commonly referred to as gas
Gas Relief
- Manufacturer
- Freds Inc
- Effective date
- 2023-11-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:19:54
Label at a glance#
ProductGas Relief Extra Strength
Active ingredientDIMETHICONE
Label structure10 sections
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 unless directed by a doctor
Storage and handling
store between 15-30°C (59-86°F) do not refrigerate protect from light, heat, and moisture
Contacts and useful links#
Websitewww.fredsinc.com
www.fredsinc.com
www.fredsinc.comLabel contents#
Full prescribing information#
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
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 unless directed by a doctor
Other information
- store between 15-30°C (59-86°F)
- do not refrigerate
- protect from light, heat, and moisture
Inactive ingredients
D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide
*contains one or more of these ingredients
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
SMALL, EASY TO SWALLOW
Extra Strength Gas Relief
Simethicone 125 mg
Antigas
Fast Relief of:
- Pressure
- Bloating
- Discomfort
†Compare to Active Ingredient in Gas-X® Extra Strength
SOFTGELS
†This product is not manufactured or distributed by GSK, distributor of Gas-X® Extra Strength
TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
Product Label
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55315-487-30 | 2021-10-19 | C162847 | 48780-1 | ba0f9c33-20c6-a910-e053-dadaa90a0b85 | Drug Facts |
| 55315-487-30 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-20c6-a910-e053-dadaa90a0b85 | Drug Facts |
Products#
Every source-derived product name is available through these pages.
- Gas Relief Extra Strength
- SIMETHICONE
- DIMETHICONE
- D&C YELLOW NO. 10
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GELATIN
- GLYCERIN
- PEPPERMINT OIL
- WATER
- SORBITAN
- SORBITOL
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55315-487 | 55315-487-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIMETHICONE | 92RU3N3Y1O | ACTIB |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| SORBITOL | 506T60A25R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
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 |
|---|---|---|---|---|---|---|
| f8bbef28-8730-4d30-8862-3ad2f8550442 | 890347c0-ed49-42b2-8334-8bf44223bf41 | 2023-11-28 | Warnings | f8bbef28-8730-4d30-8862-3ad2f8550442 890347c0-ed49-42b2-8334-8bf44223bf41 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.