SIMETHICONE- simethicone 180 mg capsule, liquid filled

SIMETHICONE by

Drug Labeling and Warnings

SIMETHICONE by is a Otc medication manufactured, distributed, or labeled by SHANDONG ROSEMED BIOOHARM LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each capsule)

Simethicone 180 mg

Purpose

Anti-gas

Uses

relieves bloating, pressure or fullness commonly referred to as gas

Warnings

Stop use and ask a doctorif condition persists

Keep out of reach of children.

Other information

store at room temperature 59º - 86ºF (15º - 30ºC)

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

Inactive ingredients

FD&C yellow#6, gelatin, glycerin, purified water and white edible ink

keep out of reach of children

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SIMETHICONE 
simethicone 180 mg capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84328-002
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	orange	Score	score with uneven pieces
Shape	CAPSULE ((oval))	Size	10mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84328-002-01	1 in 1 BOX	08/26/2024
1		25000 in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M002	08/26/2024

Labeler - SHANDONG ROSEMED BIOOHARM LLC (416829348)

Registrant - SHANDONG ROSEMED BIOOHARM LLC (416829348)

Establishment
Name	Address	ID/FEI	Business Operations
SHANDONG ROSEMED BIOOHARM LLC		416829348	manufacture(84328-002)