Assured 44-608-Delisted

Drug Labeling and Warnings

Drug Details [pdf]

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

GAS RELIEF  EXTRA STRENGTH
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-0608
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 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
Color	PINK	Score	2 pieces
Shape	ROUND	Size	14mm
Flavor	CHERRY	Imprint Code	44;608
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-0608-4	2 in 1 BOX	07/01/2013	07/08/2019
1		9 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	07/01/2013	07/08/2019

Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(33992-0608)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(33992-0608)

Revised: 8/2016

Document Id: 1ae27047-8ceb-4fc8-bc78-a2c07a2a6c31

Set id: 627aaf5a-969e-47bc-ac6c-44663914170f

Version: 4

Effective Time: 20160815