GAS RELIEF EXTRA STRENGTH- dimethicone capsule, liquid filled 
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 125 mg

Purpose

Antiflatulent (Antigas)

Use

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

Warnings

Stop use and ask a doctor if

condition persists

If pregnant or breast- feeding,

 ask a health care professional before use

Keep out of reach of children.

 In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)
  • protect from heat and moisture

Inactive Ingredients

D&C Yellow #10, edible ink, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil, purified water, sorbitol special, and titanium dioxide

Questions or comments?

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

Principal Display Panel

Compare to Extra Strength Gas-X® active ingredient*

Gas Relief

Extra Strength

Simethicone 125 mg

Relieves gas symptoms

*This product is not manufactured or distributed by Novartis consumer health, Inc., owner of the registered trademark Extra strength Gas-X®

Another quality product distributed by McKesson

one post street, San Francisco, CA 94104

Money back gurantee

Please visit us at www.sunmarkbrand.com

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

EACH DOSE IS INDIVIDUALLY SEALED IN A BLISTER PACK. DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.


Product Label

 Sunmark gas relief extra strength

Simethicone 125 mg

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49348-946
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 
PEPPERMINT OIL 
WATER 
SORBITOL 
TITANIUM DIOXIDE 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize9mm
FlavorImprint Code PO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-946-442 in 1 BOX
115 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34704/12/2011
Labeler - McKesson (Sunmark) (177667227)

Revised: 9/2012
Document Id: f986195f-5b08-4c10-bab6-44fd7855653e
Set id: 9b1d8b51-4dbc-47a9-a330-b460ba86a6dd
Version: 3
Effective Time: 20120925
 
McKesson (Sunmark)