SIMETHICONE- simethicone capsule, liquid filled
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Simethicone Capsules 180 mg

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.

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:

Inspect immediate 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

Simethicone 180mg

SIMETHICONE
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53345-036
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:53345-036-01	1 in 1 BOX	07/25/2016
1		25000 in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	07/25/2016

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

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