GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled 
EQUATE (Wal-Mart Stores, Inc.)

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 comments?

Call 1-888-287-1915

Principal Display Panel

Compare to Gas-X® Active Ingredient†

Extra Strength

Gas Relief

Simethicone 125 mg

Anti-Gas

Fast Relief of:

• Pressure   • Bloating   • Discomfort

SOFTGELS

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

Distributed by: Wal-Mart Stores, Inc.

Bentonville, AR 72716

†This product is not manufactured or distributed by Novartis, owner of the registered trademark Gas-X®

Product Label

Simethicone 125 mg

Equate Extra Strength Gas Relief Softgels

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-242
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:49035-242-202 in 1 CARTON10/15/201312/31/2020
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:49035-242-724 in 1 CARTON10/15/201312/31/2020
218 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:49035-242-142 in 1 PACKAGE10/15/201312/31/2020
372 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:49035-242-15150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/15/201312/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34710/15/201312/31/2020
Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)

Revised: 12/2018
Document Id: bc36765c-6990-45b6-abf8-0570c5f24e29
Set id: 38f296af-1c0e-4bcc-aa85-3f3e88166a3e
Version: 5
Effective Time: 20181210
 
EQUATE (Wal-Mart Stores, Inc.)