GAS RELIEF ULTRA STRENGTH- simethicone capsule, liquid filled 
LIVE BETTER (The Great Atlantic & Pacific Tea Company)

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

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

Other information

Inactive ingredients

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

Questions or comments?

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

Principal Display Panel

*Compare to the active ingredient in Phazyme® Ultra Strength

Ultra Strength

Gas Relief

Simethicone 180 mg

Antigas

Softgels

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

DISTRIBUTED BY ONPOINT, INC.

2 PARAGON DRIVE

MONTVALE, NJ 07645

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

Simethicone 180 mg softgels

GAS RELIEF  ULTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53187-530
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:53187-530-601 in 1 CARTON
160 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33208/17/2010
Labeler - LIVE BETTER (The Great Atlantic & Pacific Tea Company) (001367366)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 4/2014
Document Id: dcff1462-4615-46d6-9e32-b632b3679f6a
Set id: dda3c826-143e-420c-817e-d46d0ee523fb
Version: 2
Effective Time: 20140424
 
LIVE BETTER (The Great Atlantic & Pacific Tea Company)