GAS RELIEF EXTRA STRENGTH - dimethicone capsule, liquid filled
Kareway Product, Inc.

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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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67510-0172
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (DIMETHICONE)	DIMETHICONE	125 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
GELATIN
GLYCERIN
WATER
TITANIUM DIOXIDE

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	9mm
Flavor		Imprint Code	GR
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:67510-0172-1	10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	09/01/2012

Labeler - Kareway Product, Inc. (121840057)

Establishment
Name	Address	ID/FEI	Operations
R&P Korea Co., Ltd._Hwaseong Branch		687941593	manufacture

Revised: 10/2012 Kareway Product, Inc.