FDA.reportPublic FDA data

GENDOSE - SIMETHICONE 80 mg CHEWABLE TABLETS (77333-812)

Manufacturer
Gendose Pharmaceuticals, LLC
Effective date
2024-01-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:12:00

Label at a glance#

ProductSIMETHICONE 80MG
Active ingredientDIMETHICONE
Label structure9 sections

Indications and uses

RELIEVES GAS DISTRESS, BLOATING, AND DISCOMFORT

Dosage and administration

ADULTS CHEW 1 OR 2 TABLETS COMPLETELY AS NEEDED AFTER MEALS AND AT BEDTIME. DO NOT SWALLOW TABLETS WHOLE. DO NOT EXCEED 6 TABLETS IN 24 HOUR PERIOD EXCEPT UNDER THE ADVICE AND SUPERVISION OF A PHYSICIAN.

Storage and handling

EACH TABLET CONTAINS: CALCIUM 60MG STORE AT ROOM TEMPERATURE

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH TABLET)

OTC - ACTIVE INGREDIENT SECTION

SIMETHICONE 80MG

PURPOSE

OTC - PURPOSE SECTION

ANTI-GAS

USES

INDICATIONS & USAGE SECTION

  • RELIEVES GAS DISTRESS, BLOATING, AND DISCOMFORT

WARNINGS

WARNINGS SECTION

  • GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY AT 1-800-222-1222.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • ADULTS CHEW 1 OR 2 TABLETS COMPLETELY AS NEEDED AFTER MEALS AND AT BEDTIME. DO NOT SWALLOW TABLETS WHOLE.
  • DO NOT EXCEED 6 TABLETS IN 24 HOUR PERIOD EXCEPT UNDER THE ADVICE AND SUPERVISION OF A PHYSICIAN.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • EACH TABLET CONTAINS: CALCIUM 60MG
  • STORE AT ROOM TEMPERATURE

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

DEXTROSE, FLAVOR, MAGNESIUM STEARATE, MALTODEXTRIN, MICROCRYSTALLINE CELLULOSE, SILICA, TRIBASIC CALCIUM PHOSPHATE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Simethicone_80mg_100 tablets01b LBL_Simethicone_80mg_100 tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
314216simethicone 80 MG Chewable TabletPSN6
314216simethicone 80 MG Chewable TabletSCD6

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77333-812-102024-05-02C16284748780-11030e365-36c0-111a-e063-dadaa90a10e2GENDOSE - SIMETHICONE 80 mg CHEWABLE TABLETS (77333-812)
77333-812-102024-01-30C16284748780-11030e365-36c0-111a-e063-dadaa90a10e2GENDOSE - SIMETHICONE 80 mg CHEWABLE TABLETS (77333-812)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77333-812-10SIMETHICONE 80MG100 in 1 BOXTABLET, CHEWABLE1006
77333-812-25SIMETHICONE 80MG1 in 1 BLISTER PACKTABLET, CHEWABLE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77333-812SIMETHICONE 80MG (SIMETHICONE) TABLET, CHEWABLE [GENDOSE PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 2 package rows20240504_e7f470cf-f036-afd9-e053-2995a90a9186.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77333-812-10EA - Each77333-8122df148c8-f505-4408-8018-d6bad416cded12022-10-06
77333-812-25EA - Each77333-812ef4bf287-d8f8-405e-9c5e-d381af05b35712022-10-06

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77333-81277333-812-25, 77333-812-10

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
MAGNESIUM STEARATE70097M6I30IACT
DEXTROSEIY9XDZ35W2IACT
MALTODEXTRIN7CVR7L4A2DIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
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
0e765edc-264e-533a-e063-6394a90a7c53e7f470cf-f036-afd9-e053-2995a90a91862024-01-08WarningsExact identifier
spl id: 0e765edc-264e-533a-e063-6394a90a7c53
spl set id: e7f470cf-f036-afd9-e053-2995a90a9186

Reported adverse events (FAERS/openFDA)#

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