Simethicone

Manufacturer: WALGREEN CO. | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd
Effective date: 2024-11-21
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 00:38:41

Label at a glance#

ProductSimethicone

Active ingredientDIMETHICONE

Label structure10 sections

Indications and uses

relieves bloating, pressure or fullness commonly referred to as gas

Dosage and administration

swallow one or two softgels after a meal do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Contacts and useful links#

PhoneLabel contact1-855-215-8180

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Simethicone 250 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 doctor if

condition persists

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

swallow one or two softgels after a meal
do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other Information

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

D&C red # 33, FD&C blue # 1, gelatin, glycerin, purified water and white edible ink

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free: 1-855-215-8180

Package/Label Principal Display Panel – Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package/Label Principal Display Panel – Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
412111	simethicone 250 MG Oral Capsule	PSN	3
412111	simethicone 250 MG Oral Capsule	SCD	3
412111	dimethicone 250 MG Oral Capsule	SY	3

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
0363-9945-02	Simethicone	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1		3
0363-9945-02	Simethicone	12 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	12		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-9945	SIMETHICONE CAPSULE, LIQUID FILLED [WALGREEN CO.]	3	Current NDC, Legacy NDC, 2 package rows	20241123_4d523979-e3ae-47e8-9092-00fdffc8bb0b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0363-9945-02	EA - Each	0363-9945	35860694-0fbf-4fbc-a2f5-2ec2e3ca1d03	1	2022-06-06

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Simethicone
D&C RED NO. 33
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
GLYCERIN
WATER
DIMETHICONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0363-9945	0363-9945-02

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
D&C RED NO. 33	9DBA0SBB0L	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GELATIN, UNSPECIFIED	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	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	WALGREEN CO.	4d523979-e3ae-47e8-9092-00fdffc8bb0b	2024-11-21	Warnings	Exact identifier ndc (package): 0363-9945-02 ndc (product): 0363-9945 ndc11 (package): 00363994502 spl id: 27788635-ce7b-f0bb-e063-6394a90abe4b spl set id: 4d523979-e3ae-47e8-9092-00fdffc8bb0b

Reported adverse events (FAERS/openFDA)#

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