Simethicone 180 MG

Manufacturer: Farmacias De Similares TX LLC | Elysium Pharmaceuticals Ltd. | Green Star Labs, Inc.
Effective date: 2026-01-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 01:46:28

Label at a glance#

ProductSimethicone 180 MG

Active ingredientDIMETHICONE

Label structure10 sections

Indications and uses

Relieves - bloating - pressure -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.

Contacts and useful links#

PhoneLabel contact(855)-280-1079

Websitewww.drsimi.com

www.drsimi.com

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 180 mg

Purpose

OTC - PURPOSE SECTION

Antiflatulent (antigas)

Uses

INDICATIONS & USAGE SECTION

Relieves - bloating - pressure -fullness commonly referred to as gas

Warnings

WARNINGS SECTION

Warnings

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition persists.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

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.

Other information

SPL UNCLASSIFIED SECTION

Store at 15-30°C (59-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Black iron oxide, FD&C Yellow No. 6, Gelatin, Glycerin, Peppermint oil, Sorbitol, Titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

(855)-280-1079

SPL UNCLASSIFIED SECTION

* This product is not affiliated with the owner of the trademark Ultra Strength Phazyme®.

Distributed in USA by: FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA
customerservice@drsimi.com www.drsimi.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel

Dr. Simi

Compare to the active ingredient in Ultra Strength Phazyme®*

NDC: 85786-401-24

Simethicone 180 mg

Antigas

Relieves pressure, bloating & fullness.

24 Softgels

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85786-401-24	Simethicone 180 MG	24 in 1 CARTON	CAPSULE, LIQUID FILLED	24		1

Products#

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

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

Simethicone 180 MG
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
GELATIN
DIMETHICONE
PEPPERMINT OIL
GLYCERIN
FERROSOFERRIC OXIDE
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
85786-401	85786-401-24

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
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GELATIN	2G86QN327L	IACT
DIMETHICONE	92RU3N3Y1O	ACTIB
PEPPERMINT OIL	AV092KU4JH	IACT
GLYCERIN	PDC6A3C0OX	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
SORBITOL	506T60A25R	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
Simethicone 180 MG	SIMETHICONE 180 MG	Farmacias De Similares TX LLC	4b2166f7-8d98-dd76-e063-6394a90a7f0f	2026-01-01	Warnings	Exact identifier ndc (package): 85786-401-24 ndc (product): 85786-401 ndc11 (package): 85786040124 spl id: 4b2166f7-8d99-dd76-e063-6394a90a7f0f spl set id: 4b2166f7-8d98-dd76-e063-6394a90a7f0f

Reported adverse events (FAERS/openFDA)#

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