Your browser does not support JavaScript! GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [PURAVATION PHARMACEUTICALS INC]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

GAS RELIEF EXTRA STRENGTH (simethicone) capsule, liquid filled
[PuraVation Pharmaceuticals Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Uses for relief of:

  • pressure, bloating, and fullness commonly refered to as gas

Warnings

Keep out of reach of children.

Directions

  • adults: swallow with water 1 or 2 softgels as needed after meals or at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other information

  • store at room temperature 15°-30°C (59°-86°F)
  • protect from light, heat and moisture

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

  • Bloating
  • Pressure
  • Fullness

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
 
PuraVation Pharmaceuticals Inc

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services