FDA.reportPublic FDA data

Extra Strength gas relief

Manufacturer
PUBLIX SUPER MARKETS, INC,
Effective date
2025-10-28
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:40:54

Label at a glance#

ProductExtra Strength gas relief
Active ingredientDIMETHICONE, UNSPECIFIED
Label structure8 sections

Indications and uses

pressure, bloating and fullness commonly referred to as gas.

Dosage and administration

adults: chew 1 or 2 tablets as needed after meals and at bedtime do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician.

Storage and handling

each tablet contains: calcium 45 store at room temperature protect from excessive heat and moisture

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Uses for relief of

INDICATIONS & USAGE SECTION

  • pressure, bloating and fullness commonly referred to as gas.

Warning

WARNINGS SECTION

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults:chew 1 or 2 tablets as needed after meals and at bedtime
  • do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician.

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 45
  • store at room temperature
  • protect from excessive heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red No. 30, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sucralose, tribasic calcium phosphate

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Publix

EXTRA STRENGTH

gas relief

SIMETHICONE 125 mg/ANTIGAS

CHERRY CREME FLAVOR

Natural and Artificially Flavored

  • Relieves:
  • Discomfort
  • Pressure
  • Bloating
  • *Compare to the active ingredient in Gas-X ®Extra Strength

18 CHEWABLE TABLETS

DO NOT USE IF ANY INDIVIDUAL BLISTER IS BROKEN OR OPEN

*This product is not manufactured or distributed by GSK Consumer Healthcare Inc., the distributor of GAS-X ®Extra Strength.

DISTRIBUTED BY

3300 PUBLIX CORPORATE PARKWAY

PUBLIX SUPER MARKETS, INC,

LAKELAND,FL33811

Publix.com

PUBLIX GUARANTEE:

COMPLETE SATISFACTION OR YOUR MONEY BACK

Publix Extra Strength Gas Relief Simethicone
Publix Extra Strength Gas Relief Simethicone

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
314221simethicone 125 MG Chewable TabletPSN8
314221simethicone 125 MG Chewable TabletSCD8

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-130041415393738GTIN-13: 0041415393738
EAN-13: 0041415393738
GTIN-12: 041415393738
UPC-A: 041415393738
GTIN storage (14 digits): 00041415393738		WC134CHR.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41415-110-18Extra Strength gas relief3 in 1 CARTONTABLET, CHEWABLE38
41415-110-18Extra Strength gas relief6 in 1 BLISTER PACKTABLET, CHEWABLE68

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41415-11041415-110-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
D&C RED NO. 302S42T2808BIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCRALOSE96K6UQ3ZD4IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72024-10-29full-release2026-06-01 00:30:48

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
Extra Strength gas reliefSIMETHICONEPUBLIX SUPER MARKETS, INC,029f9254-8cfd-4ea0-8691-2d87df4504332025-10-28WarningsExact identifier
ndc (package): 41415-110-18
ndc (product): 41415-110
ndc11 (package): 41415011018
spl id: 4235a6e9-0f8e-890e-e063-6294a90ac180
spl set id: 029f9254-8cfd-4ea0-8691-2d87df450433

Reported adverse events (FAERS/openFDA)#

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