FDA.reportPublic FDA data

Walgreens Extra Strength Gas Relief Chewable Tablets

Manufacturer
WALGREENS CO.
Effective date
2025-11-25
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:18:10

Label at a glance#

ProductWalgreens Extra Strength
Active ingredientDIMETHICONE, UNSPECIFIED
Label structure8 sections

Indications and uses

for the relief of Pressure, bloating and fullness commonly referred to as gas

Dosage and administration

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

Storage and handling

each tablets contains: calcium 45 mg store at room temperature protect from excessive heat and moisture DO NOT USE IF ANY INDVIDUAL BLISTER IS BROKEN OR OPEN

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Uses

INDICATIONS & USAGE SECTION

for the relief of

  • 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 to 2 tablets as needed after meals and at bedtime. Do not swallow tablets whole.
  • do not exceed 4 tablets in a 24 hours except under the advice and supervision of a physician.

Other information

STORAGE AND HANDLING SECTION

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

DO NOT USE IF ANY INDVIDUAL BLISTER IS BROKEN OR OPEN

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red No. 30, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sucralose, tribasic calcium phosphate, FD&C red 40

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens

NDC 0363-0118-18

*Compare to GAS-X ®Extra Strength active ingredient ††

Gas Relief

SIMETHICONE 125 mg/ANTI-GAS

EXTRA STRENGTH

CHEWABLE

For fast relief of pressure, bloating & discomfort

CHERRY FLAVOR

NATURALLY AND ARTIFICIALLY FLAVORED

18 CHEWABLE TABLETS

K PAREVE

††This product is not manufactured or distributed by GSK Consumer Healthcare, Inc. the distributor of Gas-X ®Extra strength.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

Walgreens 100% SATISFACTION GUARANTEED

Walgreens.com ©2017 Walgreen Co.

MADE IN U.S.A.

IMPORTANT:Keep this carton for future reference on full labeling.

Walgreens Extra Strength 18 Chewable Tablets
Walgreens Extra Strength 18 Chewable Tablets

Package Label for 48 Chewable Tablets

SPL UNCLASSIFIED SECTION

Walgreen Extra Strength 48 Chewable Tablets
Walgreen Extra Strength 48 Chewable Tablets

Package Label for 09 Chewable Tablets

SPL UNCLASSIFIED SECTION

Walgreen Extra Strength 09 Chewable Tablets
Walgreen Extra Strength 09 Chewable Tablets

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0118-09WalgreensExtra Strength9 in 1 BOTTLE, PLASTICTABLET, CHEWABLE98
0363-0118-18WalgreensExtra Strength9 in 1 BLISTER PACKTABLET, CHEWABLE98
0363-0118-18WalgreensExtra Strength2 in 1 CARTONTABLET, CHEWABLE28
0363-0118-48WalgreensExtra Strength4 in 1 CARTONTABLET, CHEWABLE48
0363-0118-48WalgreensExtra Strength12 in 1 BLISTER PACKTABLET, CHEWABLE128

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
0363-01180363-0118-18, 0363-0118-48, 0363-0118-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
D&C RED NO. 302S42T2808BIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
CHERRYBUC5I9595WIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCRALOSE96K6UQ3ZD4IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
FD&C RED NO. 40WZB9127XOAIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB

Source Document#

Source XML

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
Walgreens Extra StrengthSIMETHICONEWALGREENS CO.dbd2ed5b-14b1-4bdf-bd0a-84579ca3d8152025-11-25WarningsExact identifier
ndc (package): 0363-0118-18
ndc (package): 0363-0118-09
ndc (package): 0363-0118-48
ndc (product): 0363-0118
ndc11 (package): 00363011818
ndc11 (package): 00363011848
ndc11 (package): 00363011809
spl id: 44698c74-8eef-961f-e063-6394a90ab6a1
spl set id: dbd2ed5b-14b1-4bdf-bd0a-84579ca3d815

Reported adverse events (FAERS/openFDA)#

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