GAS RELIEF EXTRA STRENGTH- simethicone tablet, chewable 
GREENBRIER INTERNATIONAL, INC.

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.

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Assured 44-608-Delisted

Active ingredient (in each tablet)

Simethicone 125 mg

Purpose

Antigas

Use

for the relief of pressure, bloating, and fullness commonly referred to as gas

Warnings

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • adults: chew 1 or 2 tablets as needed after meals and at bedtime
  • do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician

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 moisture
  • see end flap for expiration date and lot number

Inactive ingredients

cherry flavor, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates, FD&C red #40 aluminum lake, silica gel, sorbitol, starch, stearic acid, talc, tri-calcium phosphate

Questions or comments?

1-800-426-9391

Principal display panel

ASSURED™
COMPARE TO ACTIVE INGREDIENT OF GAS-X® EXTRA STRENGTH*

EXTRA STRENGTH

Gas
Relief

• Simethicone 125 mg
  Anti-Gas

Cherry

Relief of Gas,
Pressure, Bloating,
and Discomfort

18 chewable tablets

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 ORG031360844
item # 229931
DISTRIBUTED BY: GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA23320

Assured 44-608

Assured 44-608

GAS RELIEF  EXTRA STRENGTH
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0608
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
DEXTRATES (UNII: G263MI44RU)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SORBITOL (UNII: 506T60A25R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorPINKScore2 pieces
ShapeROUNDSize14mm
FlavorCHERRYImprint Code 44;608
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-0608-42 in 1 BOX07/01/201307/08/2019
19 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33207/01/201307/08/2019
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(33992-0608)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(33992-0608)

Revised: 8/2016
Document Id: 1ae27047-8ceb-4fc8-bc78-a2c07a2a6c31
Set id: 627aaf5a-969e-47bc-ac6c-44663914170f
Version: 4
Effective Time: 20160815
 
GREENBRIER INTERNATIONAL, INC.