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 L.N.K. International, Inc., 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 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, lecithin, mineral oil, peppermint oil, purified water, titanium dioxide

Questions or comments?

1-800-426-9391 

Principal Display Panel

QUALITY
+ PLUS

NDC: 50844-964-01

*Compare to 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             ACTUAL SIZE

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Gas-X® Extra Strength.

50844    ORG121566401

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA

Product of China
Packaged and Quality Assured in the USA

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

Quality Plus 44-664

INGREDIENTS AND APPEARANCE

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50844-964
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)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
WATER (UNII: 059QF0KO0R)

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: 50844-964-01	2 in 1 CARTON	03/01/2015
1		15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 50844-964-15	5 in 1 CARTON	03/01/2015
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 50844-964-62	15 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part332	03/01/2015

Labeler - L.N.K. International, Inc. (038154464)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(50844-964)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(50844-964)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(50844-964)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(50844-964)