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Gas Relief Extra Strength by TOP CARE (Topco Associates LLC)

Medically reviewed on September 8, 2016

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 125mg
Labeler: TOP CARE (Topco Associates LLC)
NDC Code: 36800-487

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

Antigas

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

Warnings

If pregnant of breast-feeding,

ask a health 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 4 softgels in 24 hours unless directed by a doctor


Other information
  • store between 15-30ºC (59-86ºF)
  • do not refrigerate
  • protect from light, heat, and moisture

Inactive ingredients

D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

*contain one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

EXTRA STRENGTH

Gas Relief

Simethicone, 125 mg Antigas

Relieves bloating, pressure, fullness and gas

COMPARE TO GAS-X® EXTRA STRENGTH active ingredient

SOFTGELS

†This product is not manufactured or distributed by Novartis, distributor of Gas-X® Extra Strength.

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.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.com

www.topcarebrand.com

Product Label

TopCare Extra Strength Gas Relief


GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-487
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 
WATER 
SORBITAN 
SORBITOL 
TITANIUM DIOXIDE 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize9mm
FlavorImprint CodePO;SCU;L125
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-487-3030 BLISTER PACK in 1 CARTON
11 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2NDC:36800-487-5050 BLISTER PACK in 1 CARTON
21 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34708/31/2016
Labeler - TOP CARE (Topco Associates LLC) (006935977)

 
TOP CARE (Topco Associates LLC)

← See all Gas Relief Extra Strength 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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