Simethicone

Manufacturer: Advance Pharmaceutical Inc.
Effective date: 2018-12-17
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 22:57:44

Label at a glance#

ProductSimethicone

Active ingredientDIMETHICONE

Label structure10 sections

Indications and uses

relieves bloating pressure discomfort of gas which can be caused by certain foods or air swallowing

Dosage and administration

chew thoroughly 1 to 2 tablets as needed after meals and at bed time. do not exceed 6 tablets per day unless directed by a physician

Contacts and useful links#

PhoneLabel contact631-981-4600

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each chewable tablet)

Simethicone 125 mg

Purpose

OTC - PURPOSE SECTION

Antiflatulent

Uses

INDICATIONS & USAGE SECTION

relieves

bloating
pressure
discomfort of gas which can be caused by certain foods or air swallowing

Warnings

WARNINGS SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

chew thoroughly 1 to 2 tablets as needed after meals and at bed time.
do not exceed 6 tablets per day unless directed by a physician

Other Information

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

dextrose, dipac sugar, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide, sorbitol, stearic acid

Questions or Comments

OTC - QUESTIONS SECTION

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

Call 631-981-4600, 8.30 am – 4.30 pm EST Monday - Friday

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 17714-040-60 – 60 CHEWABLE TABLETS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
314221	simethicone 125 MG Chewable Tablet	PSN	4
314221	simethicone 125 MG Chewable Tablet	SCD	4

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17714-040-60	Simethicone	60 in 1 BOTTLE	TABLET, CHEWABLE	60		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17714-040	SIMETHICONE TABLET, CHEWABLE [ADVANCE PHARMACEUTICAL INC.]	4	Current NDC, Legacy NDC, 1 package rows	20181218_e11928e8-b9db-43c5-972b-33b325090dfc.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Simethicone
DEXTROSE
SUCROSE
MICROCRYSTALLINE CELLULOSE
MALTODEXTRIN
PEPPERMINT
SILICON DIOXIDE
SORBITOL
STEARIC ACID
DIMETHICONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
17714-040	17714-040-60

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
DEXTROSE	IY9XDZ35W2	IACT
SUCROSE	C151H8M554	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
PEPPERMINT	V95R5KMY2B	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SORBITOL	506T60A25R	IACT
STEARIC ACID	4ELV7Z65AP	IACT
DIMETHICONE	92RU3N3Y1O	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simethicone	SIMETHICONE	Advance Pharmaceutical Inc.	e11928e8-b9db-43c5-972b-33b325090dfc	2018-12-17	Warnings	Exact identifier ndc (package): 17714-040-60 ndc (product): 17714-040 ndc11 (package): 17714004060 spl id: 7d3cccab-252a-cd80-e053-2a91aa0acbcc spl set id: e11928e8-b9db-43c5-972b-33b325090dfc

Reported adverse events (FAERS/openFDA)#

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