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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EXTRA STRENGTH GAS RELIEF

Drug Facts

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Uses

for the relief of

Warnings

Keep out of reach of children.

Directions

Other information

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: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH GAS RELIEF 

 ANTIGAS SIMETHICONE 125 mg  30 SOFTGELS

NDC 51013-132-10

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

MB ES Gas Relief 30ct

GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-132
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorgreen (opaque) Scoreno score
Shapecapsule (oval) Size10mm
FlavorImprint Code PC2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51013-132-103 in 1 CARTON07/26/2016
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 finalpart33207/26/2016
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(51013-132) , analysis(51013-132)

Revised: 7/2016
Document Id: db03b7a1-354b-4ee0-aafa-e0149c1903dc
Set id: ce148c8a-ad2b-48b5-bb96-8bb691a48c74
Version: 1
Effective Time: 20160726
 
PuraCap Pharmaceutical LLC