GAS RELIEF ULTRA STRENGTH- simethicone capsule, liquid filled 
TOP CARE (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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Drug Facts

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antigas

Uses

for the relief of pressure and bloating commonly referred to as gas

Warnings

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

Directions

Other information

Inactive ingredients

edible white printing ink, FD&C yellow #6, gelatin, glycerin, purified water.

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

COMPARE TO GAS-X® ULTRA STRENGTH ACTIVE INGREDIENT*

ULTRA STRENGTH

Gas Relief

ANTI-GAS/SIMETHICONE, 180 mg

FAST RELIEF OF:

SOFTGELS

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed  by GSK Consumer Healthcare, distributor of Gas-X®

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.com

Product Label

Simethicone 180 mg

TOPCARE HEALTH Ultra Strength Gas Relief

GAS RELIEF  ULTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-125
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 (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize9mm
FlavorImprint Code S180
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-125-505 in 1 CARTON10/04/2010
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33210/04/2010
Labeler - TOP CARE (Topco Associates LLC) (006935977)

Revised: 12/2022
Document Id: 17e3b2d6-9cf8-469b-981d-ff772d43d3c3
Set id: b80bbb97-38f4-4cbc-82d4-e77f377cabb2
Version: 5
Effective Time: 20221219
 
TOP CARE (Topco Associates LLC)