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Gas Relief Extra Strength by Care One (American Sales Company)

Medically reviewed on January 23, 2018

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 125mg
Labeler: Care One (American Sales Company)
NDC Code: 41520-487

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

Compare to the active ingredient in Gas-X® Extra Strength†

EXTRA STRENGTH

GAS RELIEF

Simethicone 125 mg Antigas

RELIEVES:

PRESSURE, BLOATING, FULLNESS, GAS

SOFTGELS

**This product is not manufactured or distributed GSK Comsumer Healthcare, distributor of Gas-X® Extra Strength.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY FOODHOLD U.S.A., LLC

LANDOVER, MD 20785 • 1-877-846-9949

Product Label

CAREONE Extra Strength Gas Relief

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-487
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:41520-487-3030 BLISTER PACK in 1 CARTON
11 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34711/30/2016
Labeler - Care One (American Sales Company) (809183973)

 
Care One (American Sales Company)

← 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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