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Ultra Strength Gas Relief by PuraCap Pharmaceutical LLC

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 180mg
Labeler: PuraCap Pharmaceutical LLC
NDC Code: 51013-123

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

Anti-gas

Uses
  • relieves bloating, pressure or fullness commonly referred to as gas

Warnings

Stop use and ask a doctor if condition persists

Keep out of reach of children

Directions
  • swallow 1 or 2 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 room temperature 59º - 86ºF (15º - 30ºC)

Inactive ingredients

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

Questions or comments?

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

Ultra Strength Gas Relief

Simethicone 180 mg Anti-gas  60 Softgels

NDC 51013-123-22

*Compare to the active ingredient in PHAZYME® Ultra Strength

ULTRA STRENGTH GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-123
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:51013-123-221 BOTTLE in 1 CARTON
160 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33207/17/2017
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(51013-123), analysis(51013-123)

Revised: 07/2017
 
PuraCap Pharmaceutical LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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