FDA.reportPublic FDA data

Simethicone Capsules USP, 500 mg

Manufacturer
SOFTGEL HEALTHCARE PRIVATE LIMITED
Effective date
2026-09-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-09-08 02:01:51

Label at a glance#

ProductSimethicone
Active ingredientDIMETHICONE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each softgel)

Simethicone USP 500 mg

OTC - PURPOSE SECTION

Purpose

Antigas

INDICATIONS & USAGE SECTION

Use

for the relief of

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

WARNINGS SECTION

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician

OTHER SAFETY INFORMATION

Other information

  • store at controlled room temperature 15ºC-30ºC (59-86ºF)

INACTIVE INGREDIENT SECTION

Inactive ingredients

FD&C blue no.1, gelatin, glycerin, purified water, sorbitol 70%

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bulk LabelBulk LabelNDC 35916-1942-1

Simethicone Capsules USP, 500 mg

Simethicone 500 mg/ Antigas

RELIEVES GAS FAST:

  • Pressure
  • Bloating
  • Discomfort

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

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
35916-194235916-1942-1

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
DIMETHICONE92RU3N3Y1OACTIB
SORBITOL SOLUTION 70%8KW3E207O2IACT
WATER059QF0KO0RIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32026-01-28full-release2026-06-01 01:35:13
22025-10-28monthly-update2026-06-03 17:38:05
12025-04-05full-release2026-06-01 01:15:55

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
SimethiconeSIMETHICONESOFTGEL HEALTHCARE PRIVATE LIMITED3205339a-3914-4e25-e063-6394a90a07cd2026-09-04WarningsExact identifier
ndc (package): 35916-1942-1
ndc (product): 35916-1942
ndc11 (package): 35916194201
spl id: 5aa5812e-003c-49b2-e063-6394a90a31b0
spl set id: 3205339a-3914-4e25-e063-6394a90a07cd

Reported adverse events (FAERS/openFDA)#

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