EXTRA STRENGTH GAS RELIEF- simethicone capsule, liquid filled 
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.

----------

Extra Strength Gas Relief Simethicone, 125 mg Anti-Gas 15 Softgels

Active ingredient (per each softgel)

Simethicone 125 mg

Purpose

Antigas

Use

for the relief of

•
Pressure, bloating, and fullness commonly referred to as gas

Warnings

Keep out of reach of children.

Directions

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

Other information

•
store at room temperature
•
protect from light, heat, and moisture

Inactive ingredients

D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, peppermint oil, purified water, titanium dioxide

Questions or comments

1-866-467-2748

Principal Display Panel

Extra Strength Gas Relief Simeticone ,125 mg Anti-Gas 15 Softgels

*Compare to the active ingredient in Extra Strength Gas-X®

Assured

Extra Strength

Gas Relief

SIMETHICONE, 125mg

ANTI-GAS

Relieves:

•
Bloating
•
Pressure
•
Fullness
•
Gas

15 SOFTGELS

*This product is not manufactured or distributed by GSK Consumer Healthcare, Inc., the distributor of Gas-X® Extra strength.

Distributed by:

Greenbrier International, Inc.

Chesapeake, VA 23320

IMPORTANT: Keep this carton for future reference on full labeling.

DO NOT USE IF ANY INDIVIDUAL BLISTER IS BROKEN OR OPEN

EXTRA STRENGTH GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-3113
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 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)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorGREEN (Opaque) Scoreno score
ShapeOVALSize10mm
FlavorImprint Code PC2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-3113-51 in 1 CARTON01/19/2018
115 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33201/19/2018
Labeler - Greenbrier International, Inc. (610322518)

Revised: 12/2017
Document Id: b50bc466-9fd3-457c-8c7b-526b17ff8d1a
Set id: b50bc466-9fd3-457c-8c7b-526b17ff8d1a
Version: 1
Effective Time: 20171221
 
Greenbrier International, Inc.