ULTRA STRENGTH GAS RELIEF- simethicone capsule, liquid filled

Ultra Strength Gas Relief by

Drug Labeling and Warnings

Ultra Strength Gas Relief by is a Otc medication manufactured, distributed, or labeled by PuraCap Pharmaceutical LLC, 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 180 mg

Purpose

Antigas

Uses

  for the relief of 

• pressure and bloating commonly referred to as gas

Warnings

Keep out of reach of children. 

Directions

• adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
• do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician

Other information

• store at controlled room temperature 15º - 30ºC (59º - 86ºF)
• protect from heat and moisture

Inactive ingredients

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

Questions or comments?

Call: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

Ultra Strength Gas Relief

Simethicone 180 mg Antigas  50 Softgels

NDC: 51013-428-09

*Compare to the active ingredient in Gas-X® Ultra Strength

INGREDIENTS AND APPEARANCE

ULTRA STRENGTH GAS RELIEF 
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51013-428
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	PC3
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51013-428-09	5 in 1 CARTON	02/08/2018
1		10 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	02/08/2018

Labeler - PuraCap Pharmaceutical LLC (962106329)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.		421293287	manufacture(51013-428) , analysis(51013-428)