GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled 
WinCo Foods, 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

  • 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 to report an adverse event call 800-824-1706 Monday-Friday 9am-4pm MST

Principal Display Panel

**Compare to the active ingredients in GAS-X®

Extra Strength

Gas Relief

SImethicone 125 mg/antigas

Fast relief for:

Pressure, Bloating & Discomfort

Easy to swallow

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

Softgels

DISTRIBUTED BY:

WINCO FOODS, LLC, BOISE ID 83704

**This product is not manufactured or distributed by NOVARTIS, distributor of GAS-X®

www.wincofoods.com

Product Label

Simethicone 125 mg

WinCo Foods Extra Strength Gas Relief Softgels

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-231
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)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize9mm
FlavorImprint Code PO;S1;SCU
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67091-231-3030 in 1 CARTON09/30/201405/31/2021
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 finalpart34709/30/201405/31/2021
Labeler - WinCo Foods, LLC (056098817)

Revised: 6/2021
Document Id: a156e540-1302-4de2-ac1c-592055f08da8
Set id: d86a3977-20d1-44fd-b63a-5c3bda5fc10d
Version: 4
Effective Time: 20210624
 
WinCo Foods, LLC