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]

Active ingredient (in each capsule)

Simethicone 180 mg

Purpose

Anti-gas

Uses

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

WARNINGS

Warnings

Stop use and ask a doctorif condition persists

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

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL - Shipping Label

SIMETHICONE CAPSULES, 180 mg

Quantity : 25000 Capsules
NDC. No : 53345-036-01

IMPORTANT:

1. Inspect immediate upon receipt.
2. This is a bulk shipment, intended for further processing only.
3. Protect from heat, humidity, and light. Do not refrigerate.
4. 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: 53345-036
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
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	orange (clear)	Score	no score
Shape	capsule (oval)	Size	10mm
Flavor		Imprint Code	667
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53345-036-01	1 in 1 BOX	07/25/2016
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 final	part332	07/25/2016

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

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd		421293287	manufacture(53345-036) , analysis(53345-036)