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Gas Relief ultra strength by TOP CARE (Topco Associates LLC)

Medically reviewed on October 2, 2017

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 180mg
Labeler: TOP CARE (Topco Associates LLC)
NDC Code: 36800-125

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

Antigas

Uses
  • for the relief of pressure and bloating commonly referred to as gas

Warnings

If pregnant or breast-feeding,

ask a health care 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 2 softgels in 24 hours except under the advice and supervision of a physician

Other information
  • store at controlled room temperature 20º-25ºC (68º-77ºF)
  • protect from heat and moisture

Inactive ingredients

edible white printing ink, FD&C yellow #6, gelatin, glycerin, purified water.

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

Ultra strength

Gas Relief

Simethicone 180 mg

Antigas

  • Relieves bloating, pressure, fullness and gas

Softgels

Compare to GAS-X® Ultra Strength active ingredient*

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.com

Product Label

TopCare Gas Relief Softgels

GAS RELIEF  ULTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-125
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
WATER 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize9mm
FlavorImprint CodeS180
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-125-505 BLISTER PACK in 1 CARTON
110 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33210/04/2010
Labeler - TOP CARE (Topco Associates LLC) (006935977)

 
TOP CARE (Topco Associates LLC)

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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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