GAS RELIEF EXTRA STRENGTH- dimethicone capsule, liquid filled 
P and L Development of New York Corporation

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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Drug Facts

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Uses

  • for the relief of pressure, bloating, and fullness commonly referred to as gas

Warnings

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Directions


  • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours unless directed by a doctor

Other information

  • store at controlled room temperature 20°-25°C (68°-77°F)
  • protect from light, heat, and moisture

Inactive ingredients

D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, medium-chain triglycerides*, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

*may contain this ingredient

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the active ingredient in Gas-X®

Extra Strength Gas Relief

Simethicone 125 mg

Anti-Gas

Relieves:

  • Pressure
  • Bloating
  • Discomfort

SOFTGELS

Small, easy to swallow

†This product is not manufactured or distributed by Novartis, owner of the registered trademark Gas-X®.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

Simethicone 125 mg

PL Developments Extra Strength Gas Relief Softgel

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59726-242
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
MEDIUM-CHAIN TRIGLYCERIDES 
PEPPERMINT OIL 
WATER 
SORBITAN 
SORBITOL 
TITANIUM DIOXIDE 
Product Characteristics
ColorGREEN (GREEN) Scoreno score
ShapeOVAL (OVAL) Size9mm
FlavorImprint Code PO;S1;SCU
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-242-151 in 1 BOX
115 in 1 BLISTER PACK
2NDC:59726-242-101 in 1 BOX
210 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34709/30/2013
Labeler - P and L Development of New York Corporation (800014821)

Revised: 9/2013
Document Id: 1e0879fb-f8c3-4ec6-86cb-beef685b0961
Set id: 4097fb2b-9a79-4f16-a04f-0f90d22411b1
Version: 1
Effective Time: 20130924
 
P and L Development of New York Corporation