SIMETHICONE

Manufacturer: SHANDONG ROSEMED BIOOHARM LLC
Effective date: 2024-08-26
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 00:17:55

Label at a glance#

ProductSIMETHICONE

Active ingredientDIMETHICONE

Label structure9 sections

Indications and uses

relieves bloating, pressure or fullness commonly referred to as gas

Dosage and administration

swallow one or two softgels as needed after a meal do not exceed two softgels per day except under the advice and supervision of a physician

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 180 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Uses

INDICATIONS & USAGE SECTION

relieves bloating, pressure or fullness commonly referred to as gas

Warnings

WARNINGS SECTION

Stop use and ask a doctorif condition persists

Keep out of reach of children.

Other information

INFORMATION FOR PATIENTS SECTION

store at room temperature 59º - 86ºF (15º - 30ºC)

Directions

DOSAGE & ADMINISTRATION SECTION

swallow one or two softgels as needed after a meal
do not exceed two softgels per day except under the advice and supervision of a physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C yellow#6, gelatin, glycerin, purified water and white edible ink

keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
252294	simethicone 180 MG Oral Capsule	PSN	1
252294	simethicone 180 MG Oral Capsule	SCD	1
252294	dimethicone 180 MG Oral Capsule	SY	1

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
84328-002-01	2025-07-29	C162847	48780-1	3b156c62-26c4-fb37-e063-e6dba90a4e07	20935a7f-41dd-93c5-e063-6294a90aa1c4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84328-002-01	SIMETHICONE	1 in 1 BOX	CAPSULE, LIQUID FILLED	1		1
84328-002-01	SIMETHICONE	25000 in 1 BAG	CAPSULE, LIQUID FILLED	25000		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84328-002	SIMETHICONE (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [SHANDONG ROSEMED BIOOHARM LLC]	1	2 package rows	20240829_20935a7f-41dd-93c5-e063-6294a90aa1c4.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

SIMETHICONE
Simethicone 180 mg
WATER
GLYCERIN
FD&C YELLOW NO. 6
DIMETHICONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
84328-002	84328-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
FD&C YELLOW NO. 6	H77VEI93A8	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
20935a7f-41de-93c5-e063-6294a90aa1c4			20935a7f-41dd-93c5-e063-6294a90aa1c4	2024-08-26	Warnings	Exact identifier spl id: 20935a7f-41de-93c5-e063-6294a90aa1c4 spl set id: 20935a7f-41dd-93c5-e063-6294a90aa1c4

Reported adverse events (FAERS/openFDA)#

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