Your browser does not support JavaScript! GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]
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GAS RELIEF EXTRA STRENGTH (simethicone) capsule, liquid filled
[Kareway Product, Inc.]


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 Ingredients (in each softgel)

Simethicone 125mg

Purpose

Antiflatulent

Uses

For Relief of:

  • Bloating
  • Pressure
  • Fullness
  • stuffed feeling 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

  • adults: swallow with water 1 or 2 softgels as needed after meals or at bedtime. Do not exceed 4 softgels per day, unless directed by doctor.

Other information

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

Inactive ingreients

FD&C blue 1, FD&C yellow 5, gelatin, glycerin, purified water, titanium dioxide

Package/Label Principal Display Panel

image description

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0172
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
GELATIN 
GLYCERIN 
WATER 
TITANIUM DIOXIDE 
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize9mm
FlavorImprint Code GR
Contains    
Packaging
#Item CodePackage Description
1NDC:67510-0172-110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33209/01/2012
Labeler - Kareway Product, Inc. (121840057)

Revised: 10/2012
Document Id: a16753f1-eb22-4488-9d22-a954c1cc4a13
Set id: bedac20b-d197-4d6c-9ca1-72d88c2f2a5f
Version: 2
Effective Time: 20121005
 
Kareway Product, Inc.

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