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

Medically reviewed on June 5, 2018

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 125mg
Labeler: TOP CARE (Topco Associates LLC)
NDC Code: 36800-550

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 (Antigas)

Use
  • relieves bloating, pressure, or fullness 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 and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other information
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • protect from 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, sorbitol special, titanium dioxide

Questions or comments?

Call toll free: 1-888-423-0139

Principal Display Panel

EXTRA STRENGTH

Gas Relief

Simethicone, 125 mg

  • Relieves bloating, pressure, fullness and gas

COMPARE TO EXTRA STRENGTH GAS-X® active ingredient*

SOFTGELS

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.

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Extra Strength Gas-X®.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL  60007

topcare@topco.com

Product Label

Top Care Gas Relief Softgel

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-550
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 
WATER 
SORBITOL 
TITANIUM DIOXIDE 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize9mm
FlavorImprint CodePO
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-550-302 BLISTER PACK (2 BLISTER PACK) in 1 CARTON
115 CAPSULE, LIQUID FILLED (15 CAPSULE) in 1 BLISTER PACK
2NDC:36800-550-505 BLISTER PACK (5 BLISTER) in 1 CARTON
210 CAPSULE, LIQUID FILLED (10 CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34705/31/2013
Labeler - TOP CARE (Topco Associates LLC) (006935977)
Registrant - P and L Development of New York Corporation (800014821)

 
TOP CARE (Topco Associates LLC)

← See all Gas Relief Extra Strength brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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