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Ultra Strength Gas Relief by PuraCap Pharmaceutical LLC

Medically reviewed on Feb 8, 2018

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 180mg
Labeler: PuraCap Pharmaceutical LLC
NDC Code: 51013-428

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.

Ultra Strength Gas Relief

Drug Facts

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antigas

Uses

  for the relief of 

  • pressure and bloating commonly referred to as gas

Warnings

Keep out of reach of children

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

Other information
  • store at controlled room temperature 15º - 30ºC (59º - 86ºF)
  • protect from heat and moisture

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 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-428
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
WATER 
Product Characteristics
Colororange (clear) Scoreno score
Shapecapsule (oval) Size10mm
FlavorImprint CodePC3
Contains    
Packaging
#Item CodePackage Description
1NDC:51013-428-095 BLISTER PACK in 1 CARTON
110 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33202/08/2018
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(51013-428), analysis(51013-428)

 
PuraCap Pharmaceutical LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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