GAS RELIEF EXTRA STRENGTH- dimethicone capsule, liquid filled 
PuraVation Pharmaceuticals Inc

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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GAS RELIEF EXTRA STRENGTH capsule, liquid filled

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Uses for 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?

Report serious side effects to PuraVation Pharmaceutical Inc, 1001 Durham Avenue, Suite 300, South Plainfield, NJ 07080

PRINCIPAL DISPLAY PANEL - Shipping Label

EXTRA STRENGTH

Gas Relief

NDC # 76270-103-03

*Compare to the active ingredient in EXTRA STRENGTH GAS-X®

Simethicone 125 mg

Antigas

Relieves Gas

15 SOFTGELS (125 mg each)

 

 PRINCIPAL DISPLAY PANEL - Shipping Label

GAS RELIEF EXTRA STRENGTH 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:76270-103
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
D&C YELLOW NO. 10 
GELATIN 
GLYCERIN 
PEPPERMINT OIL 
WATER 
Product Characteristics
ColorgreenScoreno score
ShapeCAPSULE (OVAL) Size9mm
FlavorImprint Code PC2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76270-103-031 in 1 CARTON
115 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33209/15/2013
Labeler - PuraVation Pharmaceuticals Inc (968385034)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.421293287MANUFACTURE(76270-103), ANALYSIS(76270-103)

Revised: 9/2013
Document Id: aff5dfcc-20a2-454b-8839-4699ac032ce9
Set id: 3dc26bf3-e0b4-4f63-a280-122c44a9d159
Version: 1
Effective Time: 20130917
 
PuraVation Pharmaceuticals Inc