EXTRA STRENGTH GAS RELIEF- simethicone capsule, liquid filled 
P & L Development, LLC

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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Extra Strength Gas Relief

Active Ingredient (in each softgel)

Simethicone 125mg

Purpose

Antiflatulent (Antigas)

Use

relieves bloating, pressure, or fullness commonly referred to as gas.

Warnings

Stop using this product and ask a doctor if condition persists. If pregnant or breastfeeding, 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 and at bedtime
  • do not exceed 4 softgelsin 24 hours except under the advice and supervision of a physician.

Other information

  • store at controlled room temperature (15°-30°C (59°-86°F)
  • *This product is not manufactured or distributed by Novartis Consumer Health, owner of the registered trademark Extra Strength Gas-X(R).

Inactive Ingredients

DandC Yellow #10, edible ink, FDandC Blue #1, FDandC Red #40, gelatin, glycerin, peppermint oil, purified water, sorbitol special, and titanium dioxide

Questions or comments?

call toll free: 1-877-753-3935

Distributed by:
PL Developments
Westbury, NY 11590, USA


EACH DOSE IS INDIVIDUALLY SEALED IN A BLISTER PACK.
DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.

KEEP OUTER CARTON FOR COMPLETE
WARNINGS AND PRODUCT INFORMATION

NDC 59726-550-30

*Compare to the active ingredient in Extra Strength Gas-X (R)

Extra Strength

Gas Relief

Simethicone, 125mg

Antigas



Relieves Bloating, Pressure, Fullness and Gas

30softgels


Product Packaging

Extra Strength Gas Relief
EXTRA STRENGTH GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-550
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorGREEN (GREEN) Scoreno score
ShapeOVAL (OVAL) Size9mm
FlavorImprint Code PO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-550-301 in 1 BOX
130 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33209/01/201112/31/2016
Labeler - P & L Development, LLC (800014821)

Revised: 3/2016
Document Id: ff3ec624-f93e-44de-91e7-e1133fa49228
Set id: ef44a608-6bc8-4786-aa88-5f5f8ad000e9
Version: 3
Effective Time: 20160302
 
P & L Development, LLC