GAS RELIEF ULTRA 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 180 mg

Purpose

Antiflatulent (Antigas)

Use

  • relieves bloating, pressure, or fullness commonly referred to as gas

Warnings

Stop using this product and ask a doctor if

condition persists.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • swallow one or two softgels as needed after a meal
  • do not exceed two softgels per day except under the advice and supervision of a physician

Other information

  • store at controlled room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

edibile ink, FD&C yellow # 6, gelatin, glycerin and purified water

Questions or comments?

1-888-287-1915

Principal Display Panel

Compare to Ultra Strength Phazyme® Active Ingredient*

Ultra Strength

Gas Relief

Anti-Gas/Simethicone

Relief of:

  • Gas discomfort
  • Pressure
  • Bloating

180 mg LIQUID-FILLED SOFTGELS

Distributed by: Wal-Mart Stores, Inc., Bentonville, AR  72716  ©Wal-Mart Stores, Inc. Product of USA

*This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Ultra Strength Phazyme®.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

EACH DOSE IS INDIVIDUALLY SEALED IN A BLISTER PACK. DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.

Package Label

Simethicone 180 mg

Equate Simethicone 180 mg Ultra Strength Gas Relief Softgels

 

GAS RELIEF  ULTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-530
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize12mm
FlavorImprint Code S180
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-530-202 in 1 CARTON01/15/201312/31/2020
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33201/15/201312/31/2020
Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)
Registrant - P & L Development, LLC (079765031)

Revised: 12/2019
Document Id: d1c78fd5-2b4d-40da-8f34-5964422daf29
Set id: 1f8af32c-2942-40c0-a9ca-98297b6aa30c
Version: 5
Effective Time: 20191212
 
EQUATE (Wal-Mart Stores, Inc.)