GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled 
Care One (American Sales Company)

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.

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Drug Facts

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Uses

Warnings

If pregnant of breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Directions

Other information

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


Simethicone 125 mg

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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize9mm
FlavorImprint Code PO;SCU;L125
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-487-3030 in 1 CARTON11/30/201602/28/2025
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/30/201602/28/2025
Labeler - Care One (American Sales Company) (809183973)

Revised: 11/2022
Document Id: bbc8f12a-f075-4bc5-85af-93e18d67cb11
Set id: ef1c668c-4af3-40b1-ba38-2f37becdfe07
Version: 5
Effective Time: 20221121
 
Care One (American Sales Company)