GAS RELIEF ULTRA STRENGTH- simethicone 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 ULTRA STRENGTH capsule, liquid filled

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antiflatulent

Uses for relief of:

  • bloating
  • pressure
  • fullness
  • stuffed feeling commonly referred to as gas

Warnings

Stop use and ask a doctor if condition persists.

If pregnant or breast-feeding, ask a health care professional before use. 

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • swallow 1 or 2 softgels as needed after meals
  • do not exceed 2 softgels per day unless directed by doctor

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)
  • protect from heat and moisture
  • do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

FD&C yellow#6, gelatin, glycerin, purified water, and white edible ink

PRINCIPAL DISPLAY PANEL

GAS RELIEF

ULTRA STRENGTH

ANTI-GAS/Simethicone 180 mg

Easy to Swallow Softgels

For Fast Relief of Pressure, Bloating & Gas Distress

60 SOFTGELS (180 mg each)

Compare to the Active Ingredient in PHAZYME® Ultra Strength

PRINCIPAL DISPLAY PANEL - Shipping Label
GAS RELIEF ULTRA STRENGTH 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76270-104
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColororangeScoreno score
ShapeCAPSULE (oval) Size11mm
FlavorImprint Code PC3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76270-104-221 in 1 CARTON04/15/201312/30/2016
160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/15/201312/30/2016
Labeler - PuraVation Pharmaceuticals Inc (968385034)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.421293287MANUFACTURE(76270-104) , ANALYSIS(76270-104)

Revised: 12/2016
Document Id: 4dab7d0d-f3f5-4bce-be80-6e3c411db16a
Set id: b9342f55-5cf9-4903-9cba-b198847fa0b9
Version: 2
Effective Time: 20161230
 
PuraVation Pharmaceuticals Inc