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 Major Pharmaceuticals, 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?

(800)-616-2471

Principal display panel

MAJOR®

NDC: 0904-6606-36

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 Softgels

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

Distributed by MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA
Re-order No. 700831
M-17       Rev. 10/16

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

50844    ORG121566401

Product of China
Packaged and Quality Assured in the USA

Major 44-664

INGREDIENTS AND APPEARANCE

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6606
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: 0904-6606-36	2 in 1 CARTON	03/01/2015	06/26/2021
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	06/26/2021

Labeler - Major Pharmaceuticals (191427277)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd		421293287	API MANUFACTURE(0904-6606)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(0904-6606)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(0904-6606)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(0904-6606)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(0904-6606)