EXTRA STRENGTH GAS RELIEF- simethicone capsule, liquid filled 
Shopko Stores Operating Co., 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

Antiflatulent

Uses

for relief of:

Warnings

Stop use 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

D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil and titanium dioxide. May also contain: purified water and sorbitol special.

principal display panel

 Extra Strength Gas Relief

ANTIGAS

SIMETHICONE 125 mg

Relieves:

*Compare to  Extra Strength Gas-X® active ingredient

Packaged by: PL Developments

200 hicks street

westbury, NY 11590 USA

QUESTIONS OR COMMENTS?

call toll free 1-877-753-3935

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

Product Label

SHOPKO GAS RELIEF 30 COUNT

SIMETHICONE 125 MG

EXTRA STRENGTH GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-550
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)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize9mm
FlavorImprint Code PO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37012-550-302 in 1 CARTON
115 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33206/02/2010
Labeler - Shopko Stores Operating Co., LLC. (023252638)

Revised: 8/2012
Document Id: 6328825e-75af-4446-8e0b-19dd3c7b504b
Set id: 039c2602-39db-49a3-a535-e178a76fef3d
Version: 1
Effective Time: 20120830
 
Shopko Stores Operating Co., LLC.