GAS RELIEF ULTRA STRENGTH- dimethicone capsule, liquid filled 
TOPCO ASSOCIATES LLC

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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Gas Relief Ultra Strength

Drug Facts

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antigas

Use

for the relief of

Warnings

Keep out of reach of children.

Directions

Other information

Inactive ingredients

FD&C yellow #6, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol sorbitan solution, titanium dioxide

Questions?

Call 1-888-423-0139

PRINCIPAL DISPLAY PANEL - 50 Softgel Blister Pack Carton

NDC:36800-802-67

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

Ultra Strength
Gas Relief
Softgels

ANTIGAS / SIMETHICONE 180mg

RELIEVES GAS FAST

actual size

50 Softgels

PRINCIPAL DISPLAY PANEL - 50 Softgel Blister Pack Carton
GAS RELIEF ULTRA STRENGTH 
dimethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-324
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
Glycerin (UNII: PDC6A3C0OX)  
Peppermint Oil (UNII: AV092KU4JH)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize12mm
FlavorImprint Code 792
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-324-052 in 1 CARTON05/01/2021
125 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33205/01/2021
Labeler - TOPCO ASSOCIATES LLC (006935977)

Revised: 3/2021
Document Id: 28000bbe-fb51-4773-aa81-9c966b27db1b
Set id: b9a4c876-722b-4d6c-807f-005ccf5df320
Version: 1
Effective Time: 20210305
 
TOPCO ASSOCIATES LLC