GAS RELIEF EXTRA STRENGTH- 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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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


Simethicone 125 mg

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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
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)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize9mm
FlavorImprint Code P;O;SCU;L125
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-487-1010 in 1 CARTON01/31/201604/26/2024
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:59726-487-1515 in 1 CARTON01/31/201604/26/2024
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:59726-487-16150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/31/201604/26/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/31/201604/26/2024
Labeler - P & L Development, LLC (800014821)

Revised: 10/2021
Document Id: 52363d26-2cce-4f20-9f5c-7ead7a11e812
Set id: 5623678e-6e9d-44e6-b586-326c6949284f
Version: 6
Effective Time: 20211026
 
P & L Development, LLC