GAS RELIEF EXTRA 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 Extra Strength

Drug Facts

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Use

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, 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 36800-801-67

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

Extra Strength
Gas Relief
Softgels

ANTIGAS / SIMETHICONE 125mg

FAST RELIF OF

actual size

50 Softgels

PRINCIPAL DISPLAY PANEL - 50 Softgel Blister Pack Carton
GAS RELIEF EXTRA STRENGTH 
dimethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-785
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, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize9mm
FlavorImprint Code 791
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-785-052 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: 7/2023
Document Id: 609f7ee9-9953-4f01-97ba-a724f7ce9a71
Set id: bb1c54d4-3a36-4b77-8659-2e92845d2f0e
Version: 3
Effective Time: 20230722
 
TOPCO ASSOCIATES LLC