GAS RELIEF ULTRA STRENGTH- simethicone capsule, liquid filled 
Preferred Plus (Kinray)

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 referred to as gas

Warnings

Stop using this product 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

Softgels

Gas Relief

Anti-Gas/Simethicone 180 mg

For the Relief of:  Bloating • Pressure • Fullness • Gas

Softgels

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

Distributed by: Kinray, LLC.

152-35 Tenth Avenue, Whitestone, NY  11357

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 125 mg

Preferred Plus Ultra Strength Gas Relief Softgel

GAS RELIEF  ULTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-045
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
ShapeCAPSULESize12mm
FlavorImprint Code S180
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-045-601 in 1 BOX07/07/201012/31/2019
160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33207/07/201012/31/2019
Labeler - Preferred Plus (Kinray) (012574513)
Registrant - P & L Development, LLC (800014821)

Revised: 12/2018
Document Id: 0a9ec9c1-e35f-47b0-b687-9f7a7fab94df
Set id: 594546cb-305c-42cd-bc44-3322c9476f6e
Version: 4
Effective Time: 20181220
 
Preferred Plus (Kinray)