SIMETHICONE 250MG capsule, liquid filled

Simethicone 250mg by

Drug Labeling and Warnings

Simethicone 250mg by is a Otc medication manufactured, distributed, or labeled by AMZ789 LLC, Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Simethicone 180mg

PURPOSE

relieves bloating, pressure, fullness, commonly referred to as gas

WARNINGS

stop use and ask a doctor if condition persists

if pregnant or breast-feedingm ask a health professional before use

Keep out of reach of children

DOSAGE & 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

INDICATIONS & USAGE

Uses relieves ▪ bloating ▪ pressure ▪ fullness commonly referred to as gas

INACTIVE INGREDIENT

FD&C Blue #1, FD&C Red #40, gelatin, glycerin, purified water, and white edible ink

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SIMETHICONE 250MG 
simethicone 250mg capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73629-006
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	250 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	purple	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	PC31
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73629-006-12	120 in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M002	12/01/2022

Labeler - AMZ789 LLC (117410213)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd		421293287	manufacture(73629-006)