ASSURED GAS RELIEF EXTRA STRENGTH EXTRA STRENGTH- 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.

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Assured Gas Relief Drug Facts

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Uses

for the relief of

Warnings

Keep out of reach of children

Directions

Other information

Inactive ingredients

D&C yellow 10, FD&C blue 1, gelatin, glycerin, purified water, titanium dioxide

Principal Display Panel

Compare to active ingredient in Extra Strength Gas-X®

Extra Strength

Gas Relief

Simethicone 125 mg

Anti-Gas

Relieves:

Bloating, Pressure, Fullness, Gas

15 Softgels

Assured Extra Strength Gas Relief Simethicone 125mg

Assured Gas Relief Extra Strength

ASSURED GAS RELIEF EXTRA STRENGTH  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0113
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)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize10mm
FlavorImprint Code R113
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-0113-12 in 1 CARTON
115 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33201/06/2012
Labeler - Greenbrier International, Inc. (610322518)

Revised: 1/2013
Document Id: d5b412b4-9121-42e0-8c3f-413810ade6dd
Set id: d5b412b4-9121-42e0-8c3f-413810ade6dd
Version: 1
Effective Time: 20130114
 
Greenbrier International, Inc.