DRUG FACTS

Drug Labeling and Warnings

Drug Details [pdf]

ANTIGAS GAS RELIEF EXTRA 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 125 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 care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions


  • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)
  • protect from heat and moisture

Inactive ingredients

D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, sorbitol special, and titanium dioxide

Questions or comments?

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

Principal Display Panel

*Compare to the Active Ingredient in Extra Strength Gas-X®

ANTIGAS

Gas Relief

EXTRA STRENGTH

Simethicone 125 mg

RELIVES GAS

  • Bloating
  • Pressure
  • Fullness 
  • Gas

SOFTGELS

EACH DOSE IS INDIVIDUALLY SEALED IN A BLISTER PACK.  DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Extra Strength Gas-X®.

Distributed by: Kinray, Inc.

152-35 Tenth Avenue

Whitestone, NY  11357

©2013 Kinray Inc., All Rights Reserved, PREFERRED PLUS, PREFERRED PLUS++++ and the PREFERRED PLUS logo are trademarks and/or registered trademarks of Kinray Inc. All other marks are property of their respective owners.

Product Label

Preferred Plus

Simethicone 125 mg

ANTIGAS GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 61715-046
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize9mm
FlavorImprint Code PO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 61715-046-101 in 1 CARTON07/13/201012/01/2017
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 FINALpart33207/13/201012/01/2017
Labeler - Preferred Plus (Kinray) (012574513)
Registrant - P & L Development, LLC (079765031)

Revised: 9/2019
Document Id: a0763f25-dac6-422e-b214-1a605a919978
Set id: 9c6270d6-6456-42a6-9840-156e6c4683aa
Version: 2
Effective Time: 20190930