FDA.reportPublic FDA data

Simethicone

Manufacturer
Innovida Pharmaeutique Corporation
Effective date
2025-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:46:47

Label at a glance#

ProductSimethicone
Active ingredientDIMETHICONE
Label structure8 sections

Indications and uses

Relieves: pressure  bloating  symptoms referred to as gas

Dosage and administration

chew 1 to 2 tablets thoroughly 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

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 
  • bloating 
  • symptoms referred to as gas

Warnings

WARNINGS SECTION

KEEP OUT OF REACH OF CHILDREN. In case of an overdose, get medical help or contact a Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

  • chew 1 to 2 tablets thoroughly 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

SPL UNCLASSIFIED SECTION

  • do not use if inner seal is broken
  • store at room temperature
  • avoid high humidity and excessive heat, above 40°C (104° F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71800-05571800-055-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUGARCANE81H2R5AOH3IACT
MALTODEXTRIN7CVR7L4A2DIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SORBITOL506T60A25RIACT
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
46e11d8b-7a1f-e5cb-e063-6394a90a35a26638d4a9-605b-4409-ae4a-522b1da8aee62025-12-26WarningsExact identifier
spl id: 46e11d8b-7a1f-e5cb-e063-6394a90a35a2
spl set id: 6638d4a9-605b-4409-ae4a-522b1da8aee6

Reported adverse events (FAERS/openFDA)#

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