Simethicone

Manufacturer: Advance Pharmaceutical Inc.
Effective date: 2024-12-26
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:49:19

Label at a glance#

ProductSimethicone Certified Plus

Active ingredientDIMETHICONE

Label structure10 sections

Indications and uses

relieves bloating pressure fullness commonly referred to as gas

Dosage and administration

swallow 1 to 2 softgels 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

Simethicone 180 mg

Purpose

OTC - PURPOSE SECTION

Antiflatulent

Uses

INDICATIONS & USAGE SECTION

relieves

bloating
pressure
fullness commonly referred to as gas

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

swallow 1 to 2 softgels 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

FD&C Yellow #6, gelatin, glycerin, purified water, sorbitol

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 pmEST Monday - Friday

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sime

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17714-076-18	SimethiconeCertified Plus	180 in 1 BOTTLE	GEL	180		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17714-076	SIMETHICONE CERTIFIED PLUS (SIMETHICONE) GEL [ADVANCE PHARMACEUTICAL INC.]	2	Current NDC, Legacy NDC, 1 package rows	20241228_d087743f-b82f-2a5c-e053-2995a90abb20.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Simethicone Certified Plus
Simethicone
WATER
GELATIN
FD&C YELLOW NO. 6
SORBITOL
GLYCERIN
DIMETHICONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
17714-076	17714-076-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
GELATIN	2G86QN327L	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
SORBITOL	506T60A25R	IACT
GLYCERIN	PDC6A3C0OX	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 Certified Plus	SIMETHICONE	Advance Pharmaceutical Inc.	d087743f-b82f-2a5c-e053-2995a90abb20	2024-12-26	Warnings	Exact identifier ndc (package): 17714-076-18 ndc (product): 17714-076 ndc11 (package): 17714007618 spl id: 2a3255ec-164d-c398-e063-6394a90a5a02 spl set id: d087743f-b82f-2a5c-e053-2995a90abb20

Reported adverse events (FAERS/openFDA)#

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