MAJOR EXTRA 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.

----------

Active ingredient (in each softgel)

Simethicone 125 mg

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 a doctor.

Other information

  • store at controlled room temperature 15o- 30o C (59o- 86o F)
  • protect from heat and moisture
  • *This product is not manufactured or distributed by Novartis Consumer Healthcare Inc., owner of the registered trademark Extra Strength Gas-X®.

Inactive ingredients

D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil and titanium dioxide. May also contain: purified water and sorbitol special.

Questions?

Adverse Drug Event Call: (800)616-2471

 MAJOR®  Gas Free

Extra Strength Gas Relief

ANTIGAS

SIMETHICONE 125 mg

Relieves:

  • bloating
  • pressure
  • fullness
  • gas

*Compare to the active ingredient in Extra Strength Gas-X®

Distributed by:

Major Pharmaceuticals

31778 Enterprise Drive

Livonia MI 48150 USA

Product Label

 simethicone 125 mg

Major extra strength gas relief

MAJOR EXTRA STRENGTH GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5458
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 
TITANIUM DIOXIDE 
WATER 
SORBITOL 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize10mm
FlavorImprint Code PO
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5458-4630 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33209/16/1998
Labeler - Major Pharmaceuticals (191427277)

Revised: 08/2012
Document Id: 1c4d2983-d53b-40d3-abdb-200680183d03
Set id: 7ee40638-84b7-4c19-9bd1-151bcaff61ed
Version: 1
Effective Time: 20120813
 
Major Pharmaceuticals