SIMETHICONE 180 MG capsule, liquid filled

Simethicone 180 MG by

Drug Labeling and Warnings

Simethicone 180 MG by is a Otc medication manufactured, distributed, or labeled by Farmacias De Similares TX LLC, Elysium Pharmaceuticals Ltd., Green Star Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antiflatulent (antigas)

Uses

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

Warnings

Warnings

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.

Keep out of reach of children.

Directions

- 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

Store at 15-30°C (59-86°F)

Inactive ingredients

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

Questions or comments?

(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

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

INGREDIENTS AND APPEARANCE

SIMETHICONE 180 MG 
simethicone 180 mg capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85786-401
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	180 mg

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
PEPPERMINT OIL (UNII: AV092KU4JH)
GLYCERIN (UNII: PDC6A3C0OX)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	910
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85786-401-24	24 in 1 CARTON; Type 0: Not a Combination Product	01/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M002	01/01/2026

Labeler - Farmacias De Similares TX LLC (119489934)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Ltd.		863182240	manufacture(85786-401)

Establishment
Name	Address	ID/FEI	Business Operations
Green Star Labs, Inc.		118673251	pack(85786-401)