FDA.reportPublic FDA data

Antiflatulent

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
Effective date
2025-01-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:52:21

Label at a glance#

ProductAntiflatulent
Active ingredientDIMETHICONE
Label structure12 sections

Dosage and administration

chew 2 to 4 tablets thoroughly as needed after meals and at bedtime do not exceed 6 tablets per day unless directed by a physician

Storage and handling

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 80 mg

PURPOSE

OTC - PURPOSE SECTION

Antigas

USE(S)

INDICATIONS & USAGE SECTION

relieves:


  • pressure
  • bloating
  • symptoms referred to as gas

WARNINGS

WARNINGS SECTION

.

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. 

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • chew 2 to 4 tablets thoroughly as needed after meals and at bedtime
  • do not exceed 6 tablets per day unless directed by a physician

OTHER INFORMATION

STORAGE AND HANDLING SECTION

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

HOW SUPPLIED

HOW SUPPLIED SECTION

Simethicone Chewable Tablets, 80 mg are white, round, tablets, debossed with "G and 103" on one side and are supplied as:

NDC 0904-7206-60 in bottle of 100 chewable tablets

Distributed by:

Major Pharmaceuticals

Livonia, MI 48152

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

QUESTIONS

OTC - QUESTIONS SECTION

Call (800) 616-2471

Repackaging Information

SPL UNCLASSIFIED SECTION

Please reference the How Suppliedsection listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count80 mg
471610-650-04

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TNAphena Pharma Solutions - TN
Cookeville, TN 38506

20220519JK

PRINCIPAL DISPLAY PANEL - 80 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71610-650 - Simethicone 80 mg Chewable Tablet - Rx Only
Bottle Label 80 mgBottle Label 80 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
314216simethicone 80 MG Chewable TabletPSN4
314216simethicone 80 MG Chewable TabletSCD4

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
71610-650-04Antiflatulent4 in 1 BOTTLETABLET, CHEWABLE44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-650ANTIFLATULENT (SIMETHICONE) TABLET, CHEWABLE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Current NDC, Legacy NDC, 1 package rows20250112_dd2ca97e-89eb-4940-ac6e-abf1f9e1c6ea.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-650-04EA - Each71610-65039e8a1c8-7af7-48a9-ad0a-a5a24875b17412022-07-06
0904-7206-60EA - Each0904-720614cb7359-be3a-4185-8c75-a9153618462b12022-04-06

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
71610-65071610-650-04
0904-7206

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AntiflatulentSIMETHICONEMajor Pharmaceuticalsd321114e-09ac-4252-a6e6-3dbc3a451ee62025-12-03WarningsExact identifier
ndc (product): 0904-7206
AntiflatulentSIMETHICONEAphena Pharma Solutions - Tennessee, LLCdd2ca97e-89eb-4940-ac6e-abf1f9e1c6ea2025-01-10WarningsExact identifier
ndc (package): 71610-650-04
ndc (product): 71610-650
ndc11 (package): 71610065004
spl id: 2b5b34d8-29c2-fc54-e063-6394a90aaa7a
spl set id: dd2ca97e-89eb-4940-ac6e-abf1f9e1c6ea

Reported adverse events (FAERS/openFDA)#

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