Simethicone 80 mg

Manufacturer: A-S Medication Solutions
Effective date: 2021-01-14
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:36:54

Label at a glance#

ProductSimethicone 80 mg

Active ingredientDIMETHICONE

Label structure14 sections

Dosage and administration

thoroughly chew 1-2 tablets as needed after meals and at bedtime do not take more then 6 tablets per day

Storage and handling

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

Contacts and useful links#

PhoneLabel contact516-341-0666

Websitewww.reliable1labs.com

www.reliable1labs.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Use

INDICATIONS & USAGE SECTION

relieves bloating, pressure and fullness commonly referred to as gas

Warnings

WARNINGS SECTION

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

thoroughly chew 1-2 tablets as needed after meals and at bedtime
do not take more then 6 tablets per day

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

compressible sugar, dextrose, maltodextrin, micdocrystalline cellulose, peppermint flavor, Silicon dioxide, sorbitol, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

call 516-341-0666, 8:30 am to 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

Distributed by: Reliable 1 Laboratories LLC

Valley Stream, NY 11580

www.reliable1labs.com

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 80 mg

Purpose

OTC - PURPOSE SECTION

Antiflatulent

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-5431

NDC: 50090-5431-3 30 TABLET, CHEWABLE in a BOTTLE

SIMETHICONE 80 MG (SIMETHICONE) TABLET, CHEWABLE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
314216	simethicone 80 MG Chewable Tablet	PSN	1
314216	simethicone 80 MG Chewable Tablet	SCD	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-5431-3	2023-01-30	C162847	48780-1	f386c649-adae-0266-e053-dadaa90a7c1a	Simethicone 80 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-5431-3	Simethicone 80 mg	30 in 1 BOTTLE	TABLET, CHEWABLE	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5431	SIMETHICONE 80 MG (SIMETHICONE) TABLET, CHEWABLE [A-S MEDICATION SOLUTIONS]	1	Legacy NDC, 1 package rows	20210115_2f8257ab-b588-4727-a989-2d4b6ef7770d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69618-033-01	EA - Each	69618-033	528ab526-0fb6-4940-b880-185c047213a3	1	2016-06-14

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Simethicone 80 mg
Simethicone
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
MALTODEXTRIN
SORBITOL
STEARIC ACID
DIMETHICONE
SUCROSE
DEXTROSE, UNSPECIFIED FORM
PEPPERMINT

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50090-5431	50090-5431-3
69618-033

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
SORBITOL	506T60A25R	IACT
STEARIC ACID	4ELV7Z65AP	IACT
DIMETHICONE	92RU3N3Y1O	ACTIB
SUCROSE	C151H8M554	IACT
DEXTROSE, UNSPECIFIED FORM	IY9XDZ35W2	IACT
PEPPERMINT	V95R5KMY2B	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simethicone 80 mg	SIMETHICONE	Reliable 1 Laboratories LLC	32fb242b-7051-072c-e054-00144ff88e88	2025-01-15	Warnings	Exact identifier ndc (product): 69618-033
12341070-7a9b-49c9-81af-c088c8bc04c8			2f8257ab-b588-4727-a989-2d4b6ef7770d	2021-01-14	Warnings	Exact identifier spl id: 12341070-7a9b-49c9-81af-c088c8bc04c8 spl set id: 2f8257ab-b588-4727-a989-2d4b6ef7770d

Reported adverse events (FAERS/openFDA)#

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