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 Type HUMAN OTC DRUG Item Code (Source) NDC:76270-103
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 125 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color green Score no score
Shape CAPSULE (OVAL) Size 9mm
Flavor Imprint Code PC2
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:76270-103-03 1 in 1 CARTON
1 15 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part332 09/15/2013
Labeler - PuraVation Pharmaceuticals Inc (968385034)
Establishment
Name Address ID/FEI Business Operations
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. 421293287 MANUFACTURE(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