GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled

Gas Relief by

Drug Labeling and Warnings

Gas Relief by is a Otc medication manufactured, distributed, or labeled by GREENBRIER INTERNATIONAL, INC., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each liquid-filled capsule)

Simethicone 125 mg

Purpose

Antigas

Use

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 capsules as needed after meals and at bedtime
• do not exceed 4 capsules in 24 hours unless directed by a doctor

Other information

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• protect from light, heat and moisture
• see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN
GAS-X® EXTRA STRENGTH*

ASSURED

EXTRA STRENGTH

Gas
Relief

Simethicone 125 mg
Anti-Gas

Relief of Pressure,
Bloating, and Discomfort

Actual Size

15 Liquid Gels

TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by GSK Consumer
Healthcare S.A., owner of the registered trademark Gas-X® Extra Strength.

50844            REV0419A66462
Product of China
Packaged and Quality Assured in the USA
ITEM# 963210
DISTRIBUTED BY:
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY,
CHESAPEAKE, VA 23320

Assured 44-664

INGREDIENTS AND APPEARANCE

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-0646
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, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	GREEN (opaque)	Score	no score
Shape	OVAL	Size	9mm
Flavor		Imprint Code	664
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-0646-2	1 in 1 CARTON	03/01/2015
1		15 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	03/01/2015

Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(33992-0646)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(33992-0646)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(33992-0646)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(33992-0646)