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 or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Directions

Other information

Inactive ingredients

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


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

fast relief of

softgels

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

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

PL Developments

200 Hicks Street, Westbury, NY 11590

Product Label

Simethicone 125 mg

WELLNESS BASICS Extra Strength Gas Relief

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-097
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)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize9mm
FlavorImprint Code PO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-097-3030 in 1 CARTON08/30/201908/30/2025
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/30/201908/30/2025
Labeler - P & L Development, LLC (800014821)

Revised: 4/2023
Document Id: 52f641a2-6b2b-429c-b119-cafe9dd203d3
Set id: b58bf9be-755f-4c5b-a6f4-b60f5bf5ac3b
Version: 2
Effective Time: 20230418
 
P & L Development, LLC