GAS RELIEF ULTRA STRENGTH- simethicone capsule, liquid filled 
Preferred Pharmaceuticals Inc.

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

relieves bloating, pressure, or fullness commonly referred to 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 symptoms occur
do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other information

store between 15-30ºC (59-86ºF)
protect from heat and moisture

Inactive ingredients

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

Questions or comments?

Call 1-800-645-2158

Principal Display Panel

Compare to the active ingredient in Phazyme® Ultra Strength†

Ultra Strength

Simethicone 180 mg

Antigas

Fast relief of

Gas
Pressure
Bloating
Discomfort

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

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

Distributed by:

RUGBY® LABORATORIES

17177 N Laurel Park Drive,

Suite 233

Livonia, MI 48152

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.

Product Label

Simethicone Softgels 180mg

RUGBY LABORATORIES Ultra Strength Simethicone

GAS RELIEF  ULTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7890(NDC:0536-1306)
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)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize12mm
FlavorImprint Code 05A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-7890-330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/23/2021
2NDC:68788-7890-636 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/23/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33204/23/2021
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022REPACK(68788-7890)

Revised: 9/2023
Document Id: 44f01bc9-0559-4cbd-9313-81b7916d6e8a
Set id: 544106bc-3c80-4d43-9df3-61a931d1751e
Version: 3
Effective Time: 20230922
 
Preferred Pharmaceuticals Inc.