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Gas Relief by PuraCap Pharmaceutical LLC

Medically reviewed on Jul 13, 2018

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 125mg
Labeler: PuraCap Pharmaceutical LLC
NDC Code: 51013-109

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.

GAS RELIEF

Drug Facts

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Uses

for the relief of

  • pressure, bloating, and fullness 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 4 softgels in 24 hours except under the advice and supervision of a physician

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

Inactive ingredients

D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, white edible ink

Questions or comments?

Call toll free: 1-800-833-6278

PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH GAS RELIEF 

SIMETHICONE 125 mg ANTIGAS 30 Softgels

NDC 51013-109-10

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

EXTRA STRENGTH GAS RELIEF 

SIMETHICONE 125 mg ANTIGAS 50 Softgels

NDC 51013-109-09

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

GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-109
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
PEPPERMINT OIL 
WATER 
Product Characteristics
Colorgreen (opaque) Scoreno score
Shapecapsule (oval) Size10mm
FlavorImprint CodePC2
Contains    
Packaging
#Item CodePackage Description
1NDC:51013-109-103 BLISTER PACK in 1 CARTON
110 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2NDC:51013-109-095 BLISTER PACK in 1 CARTON
210 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33207/13/2016
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(51013-109), analysis(51013-109)

 
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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