FDA.reportPublic FDA data

Grocery Outlet Simethicone 125 mg Softgels

Manufacturer
Grocery Outlet, Inc. | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2026-03-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:52:39

Label at a glance#

ProductExtra Strength Gas Relief
Active ingredientDIMETHICONE
Label structure10 sections

Dosage and administration

adults and children 12 years and older: 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 at room temperature protect from light, heat and moisture

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

.

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Use

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 and children 12 years and older: 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 at room temperature
  • protect from light, heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Yellow #10, FD&C blue 1, FD&C red #40, gelatin, glycerol, medium chain triglyceride, peppermint oil, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

simethicone-ifc-30ssimethicone-ifc-30s

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198852simethicone 125 MG Oral CapsulePSN2
198852simethicone 125 MG Oral CapsuleSCD2
198852dimethicone 125 MG Oral CapsuleSY2

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-130810159835800GTIN-13: 0810159835800
EAN-13: 0810159835800
GTIN-12: 810159835800
UPC-A: 810159835800
GTIN storage (14 digits): 00810159835800		simethicone-ifc-30s.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85828-722-30Extra Strength Gas Relief15 in 1 BLISTER PACKCAPSULE152
85828-722-30Extra Strength Gas Relief2 in 1 CARTONCAPSULE22

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85828-72285828-722-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SORBITOL SOLUTION8KW3E207O2IACT
SORBITAN6O92ICV9RUIACT
PEPPERMINT OILAV092KU4JHIACT
GLYCERINPDC6A3C0OXIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SHELLAC46N107B71OIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
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
Extra Strength Gas ReliefSIMETHICONEGrocery Outlet, Inc.44672e28-3305-a8cc-e063-6394a90a5fef2026-03-23WarningsExact identifier
ndc (package): 85828-722-30
ndc (product): 85828-722
ndc11 (package): 85828072230
spl id: 4db0a517-b466-216f-e063-6394a90aece0
spl set id: 44672e28-3305-a8cc-e063-6394a90a5fef

Reported adverse events (FAERS/openFDA)#

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