Simethicone 73581-302

Manufacturer
YYBA
Effective date
2026-06-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-06-12 05:10:12

Label at a glance#

ProductSIMETHICONE
Active ingredientDIMETHICONE
Label structure10 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

Label contents#

Full prescribing information#

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.

Warnings

WARNINGS SECTION

If pregnant or breast-feeding, ask a health Professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

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:

SPL UNCLASSIFIED SECTION

  • Store at 15 to 30ºC (59 to 86ºF)
  • Protect from light, heat, and moisture

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Peppermint oil, Gelatin 160 Bloom, Glycerol, Liquid Sorbitol 70%, Titanium dioxide, Allura Red, Brilliant Blue FCF, Quinoline Yellow FCF, Purified water.

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-866-933-6337

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130373581301362GTIN-13: 0373581301362
EAN-13: 0373581301362
GTIN-12: 373581301362
UPC-A: 373581301362
GTIN storage (14 digits): 00373581301362
Gas Relief Label.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
73581-30273581-302-36
72090-060

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-04-23full-release2026-06-01 01:54:52

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SIMETHICONESIMETHICONEYYBA50250112-933c-ffb1-e063-6394a90aaafb2026-06-09WarningsExact identifier
ndc (package): 73581-302-36
ndc (product): 73581-302
ndc11 (package): 73581030236
spl id: 53d7d6e5-2897-ac40-e063-6394a90a8957
spl set id: 50250112-933c-ffb1-e063-6394a90aaafb
Gas ReliefSIMETHICONE 125 MGPioneer Life Sciences, LLC51dc6493-2f9f-4148-be7d-abfef1b251122026-03-10WarningsExact identifier
ndc (product): 72090-060

Reported adverse events (FAERS/openFDA)#

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