Your browser does not support JavaScript! GAS RELIEF ULTRA STRENGTH (SIMETHICONE) CAPSULE [MCKESSON (SUNMARK)]
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GAS RELIEF ULTRA STRENGTH (simethicone) capsule
[Mckesson (Sunmark)]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 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

  • 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 controlled room temperature 15o- 30o C (59o- 86o F)
  • do not use if imprinted safety seal under cap is broken or missing
  • *this product is not manufactured or distributed by Glaxosmithkline, owner of the registered trademark Ultra Strength Phazyme®.

Inactive ingredients

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

Questions or comments?

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

Principal Display Panel

Compare to ultra strength Phazyme® active ingredient*

Gas Relief

Ultra strength Antiflatulent

Relieves bloating, pressure, fullness and gas

Simethicone 180 mg each

Relieves Gas Symptoms

Another quality product distributed by McKesson

One post street, San Francisco, CA 94104

Money back gurantee

Please visit us at www.sunmarkbrand.com

Product Label

Gas relief ultra strength

Simethicone 180 mg

 

GAS RELIEF  ULTRA STRENGTH
simethicone capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49348-489
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
WATER 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize12mm
FlavorImprint Code S180
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-489-121 in 1 CARTON
160 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33207/09/2010
Labeler - Mckesson (Sunmark) (177667227)

Revised: 10/2012
 
Mckesson (Sunmark)

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