MAJOR ULTRA STRENGTH GAS RELIEF - dimethicone capsule, liquid filled
Major Pharmaceuticals

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 ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antiflatulent

Uses

for relief of

bloating
pressure
fullness
stuffed feeling commonly known as gas

Warnings

Stop use and ask a doctor if

condition persists

Keep out of reach of children.

In case of overdose, get medical help or contact a poison control center right away

Directions

adults: swallow 1 or 2 softgels as needed after meals
do not exceed 2 softgels per day, unless directed by a doctor.

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

FD&C yellow# 6, gelatin, glycerin and purified water.

Questions ?

Adverse Drug Event Call: (800) 616-2471

Principal Display Panel

MAJOR Ultra Strength Gas Relief

Antiflatulent/ Simethicone 180 mg

Rapidly relieves Bloating, Pressure, Fullness & Gas

Major Ultra Strength Gas Relief

MAJOR ULTRA STRENGTH GAS RELIEF
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-5572
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (DIMETHICONE)	DIMETHICONE	180 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
WATER

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	S180
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0904-5572-52	60 CAPSULE, LIQUID FILLED (60 CAPSULE) in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part332	06/11/2002

Labeler - Major Pharmaceuticals (191427277)

Revised: 08/2012 Major Pharmaceuticals