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 Wal-Mart Stores Inc, Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antigas

Use

 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 under the advice and supervision of a physician

Other information

• store at controlled room temperature 15º - 30ºC (59º - 86ºF)
• protect from heat and moisture
• do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

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

Questions or comments?

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PRINCIPAL DISPLAY PANEL

Ultra Strength Gas Relief

Simethicone 180 mg Anti-gas  50 Softgels

NDC: 49035-585-21

*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: 49035-585
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: 49035-585-21	50 in 1 BOTTLE; Type 0: Not a Combination Product	10/24/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	10/24/2017

Labeler - Wal-Mart Stores Inc (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.		421293287	manufacture(49035-585) , analysis(49035-585)