FDA.reportPublic FDA data

Simethicone 250mg Maximum Strength Gas Relief

Manufacturer
One2Zee Limited Liability Company
Effective date
2026-09-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-10-03 00:01:54

Label at a glance#

ProductSimethicone 250MG Maximum Strength Gas Relief
Active ingredientDIMETHICONE
Label structure9 sections

Dosage and administration

adults: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 controlled room temperature 20°-25°C (68°-77°F) protact from light, heat and moisture do not use if imprinted safety seal under cap is broken or missing

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each softgel)

Simethicone 250 mg

OTC - PURPOSE SECTION

Purpose

Antigas

INDICATIONS & USAGE SECTION

Use for the relief of

  • pressure
  • bloating
  • fullness
  • commonly referred to as gas

Warning

WARNINGS SECTION

  • Stop use and ask doctor if condition persists.
  • If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults: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 controlled room temperature 20°-25°C (68°-77°F)
  • protact from light, heat and moisture
  • do not use if imprinted safety seal under cap is broken or missing

INACTIVE INGREDIENT SECTION

D&C Red #33, FD&C Blue #1, gelatin, glycerin, povidone, purified water, sorbitol solution, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments?
Call 1-833-663-2933

Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Simethicone 250mg_bottleSimethicone 250mg_bottle

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850064173055GTIN-13: 0850064173055
EAN-13: 0850064173055
GTIN-12: 850064173055
UPC-A: 850064173055
GTIN storage (14 digits): 00850064173055		Simethicone 250mg_bottle.jpg

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55629-02355629-023-01

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
DIMETHICONE92RU3N3Y1OACTIB
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POVIDONEFZ989GH94EIACT
WATER059QF0KO0RIACT
SORBITOL SOLUTION8KW3E207O2IACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-09-15daily-update2026-09-18 01:00:51
12024-09-24full-release2026-06-01 00:20:08

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
51101e79-92b9-4330-a555-81f7cbca6ef754d8fec7-60bd-4217-a9e9-55ae6ce7f1db2024-09-24WarningsExact identifier
spl set id: 54d8fec7-60bd-4217-a9e9-55ae6ce7f1db

Reported adverse events (FAERS/openFDA)#

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