ULTRA STRENGTH GAS RELIEF- simethicone capsule, liquid filled 
Chain Drug Consortium, 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

Antiflatulent (Antigas)

Uses

  • relieves bloating, pressure, or fullness commonly known as gas

Warnings

Stop use and ask a doctor if

condition persists.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Directions

  • swallow one or two softgels as needed after a meal
  • do not exceed two softgels per day except under the advice and supervision of a physician

Other information

  • store at 15º-30ºC (59º-86ºF)

Inactive ingredients

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

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

*COMPARE TO THE ACTIVE INGREDIENT IN PHAZYME® ULTRA STRENGTH

Ultra Strength Gas Relief

SIMETHICONE 180 mg

Antigas

Fast Relief Of

  • Pressure
  • Bloating
  • Discomfort

SOFTGELS  Small, Easy to Swallow

*This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme®.

DISTRIBUTED BY:

CHAIN DRUG CONSORTIUM, LLC.

3301 NW BOCA RATON BLVD., SUITE 101

BOCA RATON, FL 33431

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

Simethicone 180 mg

Premier Value Ultra Strength Gas Relief Softgel

ULTRA STRENGTH GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-210
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
ShapeOVALSize12mm
FlavorImprint Code S180
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-210-601 in 1 CARTON07/08/201012/01/2017
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33207/08/201012/01/2017
Labeler - Chain Drug Consortium, LLC (101668460)

Revised: 12/2021
Document Id: d43b7c74-3356-4a25-8a0e-aaad37a29d3f
Set id: fbea0d52-24da-4981-b0b1-729bf1cc2edd
Version: 5
Effective Time: 20211216
 
Chain Drug Consortium, LLC