GAS RELIEF ULTRA STRENGTH- dimethicone capsule 
McKesson (Sunmark)

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

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

Other information

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 Type HUMAN OTC DRUG Item Code (Source) NDC:49348-489
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 180 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color ORANGE Score no score
Shape OVAL Size 12mm
Flavor Imprint Code S180
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49348-489-12 1 in 1 CARTON
1 60 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part332 07/09/2010
Labeler - McKesson (Sunmark) (177667227)

Revised: 5/2014
Document Id: d71d8a53-4bf0-42d5-9040-a5042f2dbf9c
Set id: 430696eb-7d18-4769-9c6f-c6ee28808497
Version: 2
Effective Time: 20140529
 
McKesson (Sunmark)