ULTRA STRENGTH GAS RELIEF- simethicone capsule, liquid filled 
PuraCap Pharmaceutical 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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Ultra Strength Gas Relief

Drug Facts

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antigas

Uses

  for the relief of 

Warnings

Keep out of reach of children

Directions

Other information

Inactive ingredients

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

Questions or comments?

Call: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

Ultra Strength Gas Relief

Simethicone 180 mg Antigas  50 Softgels

NDC 51013-428-09

*Compare to the active ingredient in Gas-X® Ultra Strength

Ultra Strength Gas Relief 50ct

ULTRA STRENGTH GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-428
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
Colororange (clear) Scoreno score
Shapecapsule (oval) Size10mm
FlavorImprint Code PC3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51013-428-095 in 1 CARTON02/08/2018
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 finalpart33202/08/2018
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(51013-428) , analysis(51013-428)

Revised: 2/2018
Document Id: 1f1348b4-3823-4c78-bb8b-8eb0df1b9b9f
Set id: 247fcde0-aec5-4e1d-b202-95785aa7f72a
Version: 1
Effective Time: 20180208
 
PuraCap Pharmaceutical LLC