FDA.reportPublic FDA data

Gas Relief

Manufacturer
Family Dollar (FAMILY WELLNESS)
Effective date
2025-11-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:16:58

Label at a glance#

ProductGas Relief
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

For the relief of pressure, bloating, and fullness commonly referred to as gas.

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

Storage and handling

store between 20-25°C (68-77°F) do not refrigerate  protect from light, heat, and moisture

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Uses

INDICATIONS & USAGE SECTION

For the relief of pressure, bloating, and fullness commonly referred to as gas.

Warnings

WARNINGS SECTION

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • store between 20-25°C (68-77°F)
  • do not refrigerate 
  • protect from light, heat, and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, mannitol, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO THE ACTIVE INGREDIENT IN GAS-X® EXTRA STRENGTH†

EXTRA STRENGTH

GAS RELIEF

FAST RELIEF

Simethicone 125 mg

Antigas

RELIEVES

  • Pressure
  • Bloating
  • Discomfort

Small, easy to swallow

SOFTGELS

†This product is not manufactured or distributed by Haleon Group of Companies, 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: MIDWOOD BRANDS LLC,

510 VOLVO PKWY, CHESAPEAKE, VA 23320

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAMILY WELLNESS Extra Strength Gas Relief
FAMILY WELLNESS Extra Strength Gas Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198852simethicone 125 MG Oral CapsulePSN6
198852simethicone 125 MG Oral CapsuleSCD6
198852dimethicone 125 MG Oral CapsuleSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130032251921025GTIN-13: 0032251921025
EAN-13: 0032251921025
GTIN-12: 032251921025
UPC-A: 032251921025
GTIN storage (14 digits): 00032251921025		gas-relief-125-mg-green-softgel-pat-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-555-30Gas Relief1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED16
55319-555-30Gas Relief30 in 1 CARTONCAPSULE, LIQUID FILLED306

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-55555319-555-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
PEPPERMINT OILAV092KU4JHIACT
WATER059QF0KO0RIACT
SORBITAN6O92ICV9RUIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MANNITOL3OWL53L36AIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42024-03-27full-release2026-06-01 00:10:16

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas ReliefSIMETHICONEFamily Dollar (FAMILY WELLNESS)04736bb0-58fa-4d6d-ac0a-761c0429f85e2025-11-19WarningsExact identifier
ndc (package): 55319-555-30
ndc (product): 55319-555
ndc11 (package): 55319055530
spl id: b50ee474-656d-4aa4-93ae-85383f2a32ce
spl set id: 04736bb0-58fa-4d6d-ac0a-761c0429f85e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.