Your browser does not support JavaScript! GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]
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GAS RELIEF EXTRA STRENGTH (simethicone) capsule, liquid filled
[Care One (American Sales Company)]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

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 or 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 at controlled room temperature 20-25°C (68-77°F)
  • protect from light, heat, and moisture

Inactive ingredients

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

*may contain this ingredient

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

GAS RELIEF

SIMETHICONE 125 mg

Antigas

Relieves

  • Pressure
  • Bloating
  • Fullness
  • Gas

SOFTGEL

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

Distributed by:

Foodhold U.S.A., LLC

Landover, MD 20785

1-877-846-9949

© 2013 Ahold Licensing, Sarl

Quality guaranteed or your money back

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.

Product Label

CareOne

Simethicone 125 mg softgels

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41520-242
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
MEDIUM-CHAIN TRIGLYCERIDES 
PEPPERMINT OIL 
WATER 
SORBITAN 
SORBITOL 
TITANIUM DIOXIDE 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize9mm
FlavorImprint Code PO;S1;SCU
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-242-362 in 1 CARTON
118 in 1 BLISTER PACK
2NDC:41520-242-302 in 1 CARTON
215 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34711/15/2013
Labeler - Care One (American Sales Company) (809183973)

Revised: 11/2013
 
Care One (American Sales Company)

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