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Gas Relief Extra Strength by GREENBRIER INTERNATIONAL, INC.

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 125mg
Labeler: GREENBRIER INTERNATIONAL, INC.
NDC Code: 33992-0646

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Assured 44-664

Active ingredients (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 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, lecithin, mineral oil, 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 Novartis Consumer
Health, Inc., owner of the registered trademark Gas-X® Extra Strength.

50844     ORG121566462

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

Assured 44-664

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0646
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
MINERAL OIL 
PEPPERMINT OIL 
WATER 
TITANIUM DIOXIDE 
Product Characteristics
ColorGREEN (opaque) Scoreno score
ShapeOVALSize9mm
FlavorImprint Code664
Contains    
Packaging
#Item CodePackage Description
1NDC:33992-0646-21 BLISTER PACK in 1 CARTON
115 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33203/01/2015
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
Establishment
NameAddressID/FEIOperations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd421293287API MANUFACTURE(33992-0646)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(33992-0646)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(33992-0646)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(33992-0646)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(33992-0646)

 
GREENBRIER INTERNATIONAL, INC.

← See all Gas Relief Extra Strength brands

Medically reviewed on Feb 9, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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