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?

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PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH GAS RELIEF 

SIMETHICONE 125 mg ANTI-GAS 20 Softgels

NDC 51013-430-08

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

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GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-430
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:51013-430-082 in 1 CARTON03/27/2018
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:51013-430-095 in 1 CARTON03/27/2018
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:51013-430-074 in 1 CARTON03/27/2018
318 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33203/27/2018
Labeler - PURACAP PHARMACEUTICAL LLC (962106329)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(51013-430) , analysis(51013-430)

Revised: 3/2018
Document Id: 51dd27fd-405d-4ca7-a14a-ed7cdae8da59
Set id: 45f5a76a-cd7c-4152-96b5-272286ad2502
Version: 1
Effective Time: 20180327
 
PURACAP PHARMACEUTICAL LLC