ULTRA STRENGTH GAS RELIEF- simethicone capsule, liquid filled
PURACAP PHARMACEUTICAL LLC

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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Ultra Strength Gas Relief

Drug Facts

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Anti-gas

Uses

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 1 or 2 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

Questions or comments?

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

Ultra Strength Gas Relief

Simethicone 180 mg Anti-gas 60 Softgels

NDC 51013-436-22

*Compare to the active ingredient in PHAZYME® Ultra Strength

ULTRA STRENGTH GAS RELIEF
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51013-436
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	PC3
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51013-436-22	1 in 1 CARTON	03/27/2018
1		60 in 1 BOTTLE; 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	03/27/2018

Labeler - PURACAP PHARMACEUTICAL LLC (962106329)

Name	Address	ID/FEI	Business Operations
Establishment
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.		421293287	manufacture(51013-436) , analysis(51013-436)