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Extra Strength Gas Relief by Shopko Stores Operating Co., LLC.

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 125mg
Labeler: Shopko Stores Operating Co., LLC.
NDC Code: 37012-550

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 125 mg

Purpose

Antiflatulent

Uses

for relief of:

  • bloating
  • pressure
  • fullness
  • stuffed feeling commonly referred to as gas

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
  • adults: swallow with water 1 or 2 softgels as needed after meals or at bedtime. Do not exceed 4 softgels per day, unless directed by a doctor.

Other information
  • store at controlled room temperature 15o- 30o C (59o- 86o F)
  • protect from heat and moisture
  • *This product is not manufactured or distributed by Novartis Consumer Healthcare Inc., owner of the registered trademark Extra Strength Gas-X®.

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:

  • bloating
  • pressure
  • fullness
  • gas

*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

SIMETHICONE 125 MG

EXTRA STRENGTH GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-550
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
PEPPERMINT OIL 
TITANIUM DIOXIDE 
WATER 
SORBITOL 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize9mm
FlavorImprint CodePO
Contains    
Packaging
#Item CodePackage Description
1NDC:37012-550-302 BLISTER PACK (2 BLISTER PACK) in 1 CARTON
115 CAPSULE, LIQUID FILLED (15 CAPSULE) 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: 08/2012
 
Shopko Stores Operating Co., LLC.

← See all Extra Strength Gas Relief brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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