Simethicone 125 mg

Manufacturer: Proficient Rx LP
Effective date: 2024-09-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 00:22:41

Label at a glance#

ProductSimethicone 125 mg

Active ingredientDIMETHICONE

Label structure13 sections

Dosage and administration

• thoroughly chew 1-2 tablets as needed after meals and at bedtime • do not take more than 4 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

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

OTC - PURPOSE SECTION

Antiflatulent

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 than 4 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, microcrystaline cellulose, peppermint flavor, silicon dioxide, sorbitol, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

call 516-341-0666, 8:30 am -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

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Mylanta®

Distributed by: Reliable 1 Laboratories LLC

Valley Stream, NY 11580

www.reliable1labs.com

Repackaged by: Proficient Rx LP

Thousand Oaks, CA 91320

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 82804-152-09

Simethicone 125 mg

ANTIFLATULENT

9 CHEWABLE TABLETS

*Compare to Active Ingredient in MYLANTA® GAS MAXIMUM STRENGTH

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
314221	simethicone 125 MG Chewable Tablet	PSN	1
314221	simethicone 125 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82804-152-09	Simethicone 125 mg	9 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	9		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82804-152	SIMETHICONE 125 MG (SIMETHICONE) TABLET, CHEWABLE [PROFICIENT RX LP]	1	Current NDC, 1 package rows	20241006_078ef54e-96b2-4e2f-bebc-9b9bcda1f90a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82804-152-09	EA - Each	82804-152	838e7369-aae6-4ccb-8a6a-3a3aff6664d6	1	2024-12-10
69618-032-06	EA - Each	69618-032	aa923b1b-9112-453b-bc6f-c3e2956863ec	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 125 mg
Simethicone
SUCROSE
DIMETHICONE
MALTODEXTRIN
PEPPERMINT
SORBITOL
STEARIC ACID
DEXTROSE, UNSPECIFIED FORM
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
82804-152	82804-152-09
69618-032

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
SUCROSE	C151H8M554	IACT
DIMETHICONE	92RU3N3Y1O	ACTIB
MALTODEXTRIN	7CVR7L4A2D	IACT
PEPPERMINT	V95R5KMY2B	IACT
SORBITOL	506T60A25R	IACT
STEARIC ACID	4ELV7Z65AP	IACT
DEXTROSE, UNSPECIFIED FORM	IY9XDZ35W2	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	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 125 mg	SIMETHICONE	Reliable 1 Laboratires LLC	330aed4b-7109-09b8-e054-00144ff8d46c	2025-01-15	Warnings	Exact identifier ndc (product): 69618-032
Simethicone 125 mg	SIMETHICONE	Proficient Rx LP	078ef54e-96b2-4e2f-bebc-9b9bcda1f90a	2024-09-01	Warnings	Exact identifier ndc (package): 82804-152-09 ndc (product): 82804-152 ndc11 (package): 82804015209 spl id: 078ef54e-96b2-4e2f-bebc-9b9bcda1f90a spl set id: 078ef54e-96b2-4e2f-bebc-9b9bcda1f90a

Reported adverse events (FAERS/openFDA)#

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