GAS RELIEF- simethicone capsule, liquid filled

Gas Relief by

Drug Labeling and Warnings

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 125 mg

Purpose

Antigas

Uses

for the relief of

• pressure, bloating, and fullness 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 4 softgels in 24 hours except under the advice and supervision of a physician

Other information

• store at room temperature 15°-30°C (59°-86°F)
• protect from light, heat and moisture

Inactive ingredients

D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, white edible ink

Questions or comments?

Call toll free: 1-800-833-6278

PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH GAS RELIEF 

SIMETHICONE 125 mg ANTIGAS 30 Softgels

NDC: 51013-109-10

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

EXTRA STRENGTH GAS RELIEF 

SIMETHICONE 125 mg ANTIGAS 50 Softgels

NDC: 51013-109-09

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

INGREDIENTS AND APPEARANCE

GAS RELIEF 
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51013-109
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	green (opaque)	Score	no score
Shape	capsule (oval)	Size	10mm
Flavor		Imprint Code	PC2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51013-109-10	3 in 1 CARTON	07/13/2016
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 51013-109-09	5 in 1 CARTON	07/13/2016
2		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	07/13/2016

Labeler - PuraCap Pharmaceutical LLC (962106329)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.		421293287	manufacture(51013-109) , analysis(51013-109)