FDA.reportPublic FDA data

Simethicone

Manufacturer
WALMART INC. | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd
Effective date
2024-11-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:38:42

Label at a glance#

ProductSimethicone
Active ingredientDIMETHICONE
Label structure9 sections

Indications and uses

relieves bloating, pressure or fullness commonly referred to as gas

Dosage and administration

swallow one or two softgels after a meal do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Simethicone 250 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Uses

INDICATIONS & USAGE SECTION

relieves bloating, pressure or fullness commonly referred to as gas

Warnings

WARNINGS SECTION

Stop use and ask a doctor if

condition persists

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • swallow one or two softgels after a meal
  • do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other Information

OTHER SAFETY INFORMATION

  • store at room temperature 59°-86°F (15°-30°C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

D&C red # 33, FD&C blue # 1, gelatin, glycerin, purified water and white edible ink

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free: 1-855-215-8180

Package/Label Principal Display Panel – Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Maximum Strength Gas Relief

Simethicone 250 mg 60ct

NDC: 79903-020-22

Bottle label frontBottle label front

Bottle label backBottle label back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
412111simethicone 250 MG Oral CapsulePSN2
412111simethicone 250 MG Oral CapsuleSCD2
412111dimethicone 250 MG Oral CapsuleSY2

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
79903-020-22Simethicone60 in 1 BOTTLECAPSULE, LIQUID FILLED602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-020SIMETHICONE CAPSULE, LIQUID FILLED [WALMART INC.]2Current NDC, Legacy NDC, 1 package rows20241123_79a9e0a3-9199-4397-ab29-b8a9c843cdf8.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79903-02079903-020-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OACTIB

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
SimethiconeSIMETHICONEWALMART INC.79a9e0a3-9199-4397-ab29-b8a9c843cdf82024-11-21WarningsExact identifier
ndc (package): 79903-020-22
ndc (product): 79903-020
ndc11 (package): 79903002022
spl id: 2778c24f-cc7a-cf24-e063-6294a90ae5a3
spl set id: 79a9e0a3-9199-4397-ab29-b8a9c843cdf8

Reported adverse events (FAERS/openFDA)#

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