GAS RELIEF ULTRA STRENGTH- dimethicone capsule, liquid filled 
EQUATE (Walmart 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.

----------

Drug Facts

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antiflatulent (Antigas)

Use

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

Other information

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:

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 Type HUMAN OTC DRUG Item Code (Source) NDC:49035-530
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 180 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color ORANGE Score no score
Shape OVAL Size 12mm
Flavor Imprint Code S180
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49035-530-20 2 in 1 CARTON
1 10 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part332 01/15/2013
Labeler - EQUATE (Walmart Stores, Inc.) (051957769)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 12/2012
Document Id: b54afe54-7e47-4438-9785-6dddafdf9185
Set id: 1f8af32c-2942-40c0-a9ca-98297b6aa30c
Version: 2
Effective Time: 20121231
 
EQUATE (Walmart Stores, Inc.)