Simethicone

Manufacturer: H-E-B
Effective date: 2020-10-20
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:32:08

Label at a glance#

ProductSimethicone

Active ingredientDIMETHICONE

Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Simethicone 250mg

OTC - PURPOSE SECTION

Anti-gas

INACTIVE INGREDIENT SECTION

D&C Red #33, FD&C Blue #1, gelatin, glycerin, povidone, purified water, sorbitol

DOSAGE & ADMINISTRATION SECTION

swallow one or two softgels as symptoms occur
do not exceed 2 softgels per 24 hours except under the advice and super vision of a physician

INDICATIONS & USAGE SECTION

relieves bloating, pressure or fullness commonly referred to as gas

WARNINGS SECTION

Stop use and ask a doctor if condition persists.

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER SAFETY INFORMATION

store at room temperature between 20-25°C (68-77ºF).
protect from heat, humidity and light.
TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS CUT TORN OR MISSING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

788

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
412111	simethicone 250 MG Oral Capsule	PSN	1
412111	simethicone 250 MG Oral Capsule	SCD	1
412111	dimethicone 250 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
37808-788-06	2022-01-28	C162847	48780-1	d6a99b39-6374-a426-e053-dadaa90af4c2	MS Gas Relief - Simethicone 250mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
37808-788-06	Simethicone	60 in 1 BOTTLE	CAPSULE, LIQUID FILLED	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-788	SIMETHICONE CAPSULE, LIQUID FILLED [H-E-B]	1	Legacy NDC, 1 package rows	20201021_b21b92f4-5889-ac05-e053-2a95a90ade4f.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Simethicone
WATER
FD&C BLUE NO. 1
SORBITOL
D&C RED NO. 33
GLYCERIN
POVIDONE
DIMETHICONE
GELATIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
37808-788	37808-788-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
SORBITOL	506T60A25R	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
GLYCERIN	PDC6A3C0OX	IACT
POVIDONE	FZ989GH94E	IACT
DIMETHICONE	92RU3N3Y1O	ACTIB
GELATIN	2G86QN327L	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
b21b90f1-ef5d-8408-e053-2a95a90ad780			b21b92f4-5889-ac05-e053-2a95a90ade4f	2020-10-20	Warnings	Exact identifier spl id: b21b90f1-ef5d-8408-e053-2a95a90ad780 spl set id: b21b92f4-5889-ac05-e053-2a95a90ade4f

Reported adverse events (FAERS/openFDA)#

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