Simethicone

Manufacturer: ONE2ZEE LIMITED LIABILITY COMPANY | Medgel Private Limited
Effective date: 2023-03-25
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:54:34

Label at a glance#

ProductSimethicone

Active ingredientDIMETHICONE

Label structure8 sections

Dosage and administration

adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Storage and handling

store at controlled room temperature 20-25ºC (68-77ºF) protect from light, heat, and moisture

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125mg

Purpose

OTC - PURPOSE SECTION

Antigas

Use

INDICATIONS & USAGE SECTION

for the relief of

pressure, bloating, and fullness commonly referred to as gas

Warning

WARNINGS SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other Information

STORAGE AND HANDLING SECTION

store at controlled room temperature 20-25ºC (68-77ºF)
protect from light, heat, and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue 1, FD&C yello#10, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan, titanium dioxide

PRINCIPAL DISPLAY PANEL - Shipping Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IMETHICONE CAPSULES, 325 mg

Quantity : 48 Bags of 1500 Capsules each
NDC. No : 55629-010-01

Important:

1. Inspect immediately upon receipt

2. This is bulk shipment intended for further processing only

3. store at controlled room temperature 20-25ºC (68-77ºF), protect from light, heat, and moisture

shipping label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198852	simethicone 125 MG Oral Capsule	PSN	3
198852	simethicone 125 MG Oral Capsule	SCD	3
198852	dimethicone 125 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55629-010-01	2025-01-30	C162847	48780-1	f386c649-a907-0266-e053-dadaa90a7c1a	Extra Strength Gas Relief
55629-010-01	2023-03-25	C162847	48780-1	f386c649-a907-0266-e053-dadaa90a7c1a	Extra Strength Gas Relief
55629-010-01	2023-01-30	C162847	48780-1	f386c649-a907-0266-e053-dadaa90a7c1a	Extra Strength Gas Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55629-010-01	Simethicone	48 in 1 CARTON	CAPSULE, LIQUID FILLED	48		3
55629-010-02	Simethicone	1500 in 1 POUCH	CAPSULE, LIQUID FILLED	1500		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55629-010	SIMETHICONE CAPSULE, LIQUID FILLED [ONE2ZEE LIMITED LIABILITY COMPANY]	3	Legacy NDC, 2 package rows	20230326_a2d1fc2d-6bb1-459d-900a-7e4f329792b1.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Simethicone
DIMETHICONE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GELATIN
GLYCERIN
PEPPERMINT OIL
Povidone K30
SORBITOL
TITANIUM DIOXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55629-010	55629-010-02, 55629-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIMETHICONE	92RU3N3Y1O	ACTIB
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
Povidone K30	U725QWY32X	IACT
SORBITOL	506T60A25R	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WATER	059QF0KO0R	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
906fa458-697b-4e53-bce8-ea6cdfaaaa32			a2d1fc2d-6bb1-459d-900a-7e4f329792b1	2023-03-25	Warnings	Exact identifier spl id: 906fa458-697b-4e53-bce8-ea6cdfaaaa32 spl set id: a2d1fc2d-6bb1-459d-900a-7e4f329792b1

Reported adverse events (FAERS/openFDA)#

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