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 Chain Drug Consortium, Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd, 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

relieves bloating, pressure, fullness, or stuffed feeling 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• protect from 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, lecithin, mineral oil, peppermint oil, purified water, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

Premier
Value®

NDC: 68016-643-30

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

Extra Strength
Gas Relief
Simethicone 125 mg

ANTIGAS

Relieves
Pressure
Bloating
Discomfort

easy to swallow

30 Liquid-filled
Capsules

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 Novartis Consumer Health, Inc.,
owner of the registered trademark Gas-X® Extra Strength.
50844               ORG091466401

Product of China
Packaged and Quality Assured in the USA

DISTRIBUTED BY
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL  33431

If for any reason you are not satisfied with
this product, please return it to the store
where purchased for a full refund.

Premier Value 44-664

INGREDIENTS AND APPEARANCE

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-643
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)
MINERAL OIL (UNII: T5L8T28FGP)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)

Product Characteristics
Color	GREEN	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: 68016-643-30	3 in 1 CARTON	03/01/2015
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	03/01/2015

Labeler - Chain Drug Consortium (101668460)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd		421293287	API MANUFACTURE(68016-643)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(68016-643)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(68016-643)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(68016-643)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(68016-643)