FDA.reportPublic FDA data

SIMETHICONE CAPSULES 250 mg, liquid filled

Manufacturer
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Effective date
2024-11-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:38:25

Label at a glance#

ProductSimethicone
Active ingredientDIMETHICONE
Label structure8 sections

Indications and uses

relieves bloating, pressure or fullness commonly referred to as gas

Dosage and administration

swallow one or two softgels after a meal do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Storage and handling

store at room temperature 59°-86°F (15°-30°C)

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 250 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Uses 

INDICATIONS & USAGE SECTION

  • relieves bloating, pressure or fullness commonly referred to as gas

Warnings

WARNINGS SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition persists

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • swallow one or two softgels after a meal
  • do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 59°-86°F (15°-30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue #1, FD&C Red #40, gelatin, glycerin, purified water, and white edible ink

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Wuhan, Hubei
430206, China

PRINCIPAL DISPLAY PANEL - Shipping Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SIMETHICONE CAPSULES, 250 mg

Quantity : 25000 Capsules
NDC. No : 53345-032-01

IMPORTANT:
1.Inspect immediate upon receipt.
2.This is a bulk shipment, intended for further processing only.
3.Protect from heat, humidity, and light. Do not refrigerate.
4.Store at 15-30°C (59-86°F)

CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

Shipping LabelShipping Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
412111simethicone 250 MG Oral CapsulePSN4
412111simethicone 250 MG Oral CapsuleSCD4
412111dimethicone 250 MG Oral CapsuleSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53345-032-01Simethicone20000 in 1 BAGCAPSULE, LIQUID FILLED200004
53345-032-01Simethicone1 in 1 BOXCAPSULE, LIQUID FILLED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53345-032SIMETHICONE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]4Current NDC, Legacy NDC, 2 package rows20241122_852cec3b-6564-46b2-afe5-ecef31424237.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O1
DIMETHICONEACTIVE MOIETY92RU3N3Y1O1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
GELATININACTIVE INGREDIENT2G86QN327L1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53345-03253345-032-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, LIQUID FILLED / ORAL0.08 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, LIQUID FILLED / ORAL1042 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, LIQUID FILLED / ORAL0.08 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, LIQUID FILLED / ORAL1042 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
SimethiconeSIMETHICONEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd0c9c5fec-ddd4-41a5-8ff9-6b55c376dd362024-11-25WarningsExact identifier
ndc (product): 53345-032
SimethiconeSIMETHICONEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.852cec3b-6564-46b2-afe5-ecef314242372024-11-21WarningsExact identifier
ndc (package): 53345-032-01
ndc (product): 53345-032
ndc11 (package): 53345003201
spl id: 2767f3c0-877c-60b0-e063-6394a90a8ebd
spl set id: 852cec3b-6564-46b2-afe5-ecef31424237

Reported adverse events (FAERS/openFDA)#

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