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

Use

For the relief of

Warnings

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

Directions

Other information

Inactive ingredients

FD&C red #40*,FD&C yellow # 6, gelatin, glycerin

Questions or comments?

Calltoll free 1-888-423-0139

Principal Display Panel

COMPARE TO GAS-X® ULTRA STRENGTH ACTIVE NGREDIENT*

ULTRA STRENGTH

Gas Relief

ANTI-GAS/SIMETHICONE, 180 mg

FAST RELIEF OF

SOFTGELS

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

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.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

www.topcarebrand.com

Package 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:36800-963
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)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize12mm
FlavorImprint Code 05A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-963-5050 in 1 BOX07/30/2020
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33207/30/2020
Labeler - TOP CARE (Topco Associates LLC) (006935977)

Revised: 11/2022
Document Id: 5ef2033d-949f-43d2-993b-2f16729cbaf1
Set id: 3be41f57-862b-472c-97a7-91d0a0a3074b
Version: 2
Effective Time: 20221128
 
TOP CARE (Topco Associates LLC)