GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled 
QUALITY CHOICE (Chain Drug Marketing Association)

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

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.

In case of overdose get medical help or contact a Poison Control Center (1-800-222-1222) right away

Directions

Other information

Inactive ingredients

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

Questions or comments?

Call 1-800-935-2362 Monday-Friday 9AM-5PM EST

Principal Display Panel

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

Gas Relief

Extra Strength

Simethicone  125 mg / Antigas

For Relief of:

Bloating

Pressure

Fullness

Gas

Softgels

†This product is not manufactured or distributed by GSK Consumer 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: C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Product Label

Simethicone 125 mg

QUALITY CHOICE Extra Strength Gas Relief

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-300
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)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize9mm
FlavorImprint Code PO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-300-3030 in 1 CARTON09/30/201909/30/2025
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 finalpart34709/30/201909/30/2025
Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Revised: 5/2023
Document Id: d7504e12-51c8-403c-90d6-31d45ee3ad6a
Set id: 7670631e-81be-49ce-862a-0923ad55ca48
Version: 2
Effective Time: 20230502
 
QUALITY CHOICE (Chain Drug Marketing Association)