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Gas Relief Extra Strength by P & L Development, LLC

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 125mg
Labeler: P & L Development, LLC
NDC Code: 59726-487

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.

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 of 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 between 15-30ºC(59-86ºF)
  • do not refrigerate
  • protect from light, heat, and moisture

Inactive ingredients

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

*contain one or more of these ingredients

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†

extra strength gas relief

simethicone 125 mg

anti-gas

relieves:

  • pressure
  • bloating
  • discomfort

small, easy to swallow

SOFTGELS

†This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Gas-X® Extra Strength.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

Product Label

READYinCASE Gas Relief Softgels

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-487
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
PEPPERMINT OIL 
WATER 
SORBITAN 
SORBITOL 
TITANIUM DIOXIDE 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize9mm
FlavorImprint CodeP;O;SCU;L125
Contains    
Packaging
#Item CodePackage Description
1NDC:59726-487-1010 BLISTER PACK in 1 CARTON
11 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2NDC:59726-487-1515 BLISTER PACK in 1 CARTON
21 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
3NDC:59726-487-16150 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34701/31/2016
Labeler - P & L Development, LLC (800014821)

 
P & L Development, LLC

← See all Gas Relief Extra Strength brands

Medically reviewed on Feb 13, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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