GAS RELIEF ULTRA STRENGTH- simethicone capsule 
Strategic Sourcing Services LLC

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 180 mg

Purpose

Antiflatulent (Antigas)

Uses

  • relieves bloating, pressure, or fullness commonly referred to as gas

Warnings

Stop using this product and ask a doctor if

condition persists.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Directions

  • swallow one or two softgels as needed after a meal
  • do not exceed two softgels per day except under the advice and supervision of a physician

Other information

  • store at 15º-30ºC (59º-86ºF)

Inactive ingredients

edible ink, FD&C yellow #6, gelatin, glycerin, purified water

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO PHAZYME® ULTRA STRENGTH ACTIVE INGREDIENT*

Gas Relief

Ultra Strength Antigas

Relieves bloating, pressure, fullness & gas

Simethicone 180 mg

RELIEVES GAS SYMPTOMS

SOFTGELS 180 mg EACH

*This product is not manufactured or distributed by C.B. Fleet Company, Inc., distributor of Phazyme®. 

Another Quality Product Distributed by McKesson

One Post Street, San Francisco, CA 94104

Please visit us at www.sunmarkbrand.com

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

Simethicone 180 mg

Sunmark Gas Relief Softgel

GAS RELIEF  ULTRA STRENGTH
simethicone capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-489
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize12mm
FlavorImprint Code S180
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-489-121 in 1 CARTON07/09/201010/28/2021
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33207/09/201010/28/2021
Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 12/2022
Document Id: 56dacdd7-91f6-4d9f-b2d7-6a575c2fbd3f
Set id: 430696eb-7d18-4769-9c6f-c6ee28808497
Version: 6
Effective Time: 20221212
 
Strategic Sourcing Services LLC