SIMETHICONE capsule, liquid filled

Simethicone by

Drug Labeling and Warnings

Simethicone by is a Otc medication manufactured, distributed, or labeled by Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

Simethicone 250 mg

Purpose

Anti-gas

Use

relieves bloating, pressure or fullness commonly referred to as gas

Warnings

Stop use and ask a doctor if

condition persists

Keep out of reach of children.

Directions

• swallow one or two softgels after a meal
• do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other information

• store at room temperature 59°-86°F (15°-30°C)

Inactive ingredients

D&C red # 33, FD&C blue # 1, gelatin, glycerin, purified water and white edible ink

PRINCIPAL DISPLAY PANEL - Shipping Label

Simethicone Capsules 250 mg

NDC: 53345-032-02

Quantity: 12 Capsules per blister

124 Blisters per box

IMPORTANT:

Inspect immediately upon receipt.
This is a bulk shipment, intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.
Store at 15-30°C (59-86°F)
CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

INGREDIENTS AND APPEARANCE

SIMETHICONE 
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53345-032
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	purple (clear)	Score	no score
Shape	capsule (oval)	Size	13mm
Flavor		Imprint Code	PC31
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53345-032-02	124 in 1 BOX	06/30/2016
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	06/30/2016

Labeler - Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd (421293287)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd		421293287	manufacture(53345-032) , analysis(53345-032)