FDA.reportPublic FDA data

Extra Strength Gas Relief Tablets

Manufacturer
WALGREENS CO.
Effective date
2025-11-25
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:18:09

Label at a glance#

ProductExtra Strength Gas Relief
Active ingredientDIMETHICONE, UNSPECIFIED
Label structure7 sections

Indications and uses

relieves pressure and bloating commonly referred to as gas

Dosage and administration

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

Storage and handling

each tablet contains : calcium 45 mg store at controlled room temperature 20-25°C (68-77°F) protect from moisture do not use if any individual blister unit 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

relieves pressure and bloating commonly referred to as gas

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

STORAGE AND HANDLING SECTION

  • each tablet contains :calcium 45 mg
  • store at controlled room temperature 20-25°C (68-77°F)
  • protect from moisture
  • do not use if any individual blister unit is broken or open

Inactive Ingredients

INACTIVE INGREDIENT SECTION

D&C yellow # 10 lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sucralose, tribasic calcium phosphate

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WALGREENS PHARMACIST RECOMMENDED‡
NDC 0363-0119-18
EXTRA STRENGTH
Gas Relief
Simethicone 125 mg/Anti-Gas
For fast Relief of:

  • Pressure
  • Bloating
  • Gas distress


PEPPERMINT CRÈME FLAVOR

18 Chewable Tablets

Compare to Extra Strength Gas-X® active ingredient‡‡

‡‡This product is not manufactured or distributed by Novartis Consumer Health, Inc., the distributor of Gas-X®.

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


Extra Strength Gas Relief 18 Chewable Tablets
Extra Strength Gas Relief 18 Chewable Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
314221simethicone 125 MG Chewable TabletPSN6
314221simethicone 125 MG Chewable TabletSCD6

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
0363-0119-18Extra Strength Gas Relief2 in 1 CARTONTABLET, CHEWABLE26
0363-0119-18Extra Strength Gas Relief9 in 1 BLISTER PACKTABLET, CHEWABLE96

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
0363-01190363-0119-18

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 YELLOW NO. 1035SW5USQ3GIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SUCRALOSE96K6UQ3ZD4IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
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
Extra Strength Gas ReliefSIMETHICONE ANTIGASWALGREENS CO.bf6f5463-a88c-4854-be4d-319582e564792025-11-25WarningsExact identifier
ndc (package): 0363-0119-18
ndc (product): 0363-0119
ndc11 (package): 00363011918
spl id: 4469a8dc-7c00-6a5d-e063-6294a90a15c5
spl set id: bf6f5463-a88c-4854-be4d-319582e56479

Reported adverse events (FAERS/openFDA)#

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