FDA.reportPublic FDA data

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

Manufacturer
Gendose Pharmaceuticals, LLC
Effective date
2026-10-06
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-10-13 04:04:47

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 any 24 hour period except under the advice and supervision of a physician.

Storage and handling

each tablet contains: calcium 60 mg store at room temperature

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 80 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Uses

INDICATIONS & USAGE SECTION

  • relieves gas distress, bloating, and discomfort

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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 any 24 hour period except under the advice and supervision of a physician.

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains:calcium 60 mg
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

dextrose, flavor, maltodextrin, microcrystalline cellulose, silica, tribasic calcium phosphate, magnesium stearate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

11

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeDataBar Omni(01)00377333812106GTIN-14: 00377333812106
GTIN-12: 377333812106
UPC-A: 377333812106
EAN-13: 0377333812106
GTIN storage (14 digits): 00377333812106		label.jpg

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)
77333-812-102024-05-02C16284748780-11030e365-36c0-111a-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)
77333-812-102024-01-30C16284748780-11030e365-36c0-111a-e063-dadaa90a10e2GENDOSE - SIMETHICONE 80 mg CHEWABLE TABLETS (77333-812)

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
DIMETHICONE92RU3N3Y1OACTIB
MAGNESIUM STEARATE70097M6I30IACT
DEXTROSEIY9XDZ35W2IACT
MALTODEXTRIN7CVR7L4A2DIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-01-08full-release2026-06-01 00:12:00

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 set id: e7f470cf-f036-afd9-e053-2995a90a9186

Reported adverse events (FAERS/openFDA)#

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