Your browser does not support JavaScript! MAJOR EXTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]
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MAJOR EXTRA STRENGTH GAS RELIEF (simethicone) capsule, liquid filled
[Major Pharmaceuticals]


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 125 mg

Purpose

Antiflatulent (Antigas)

Uses

  • relieves bloating, pressure, or fullness 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 and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other information

  • store at 15o- 30o C (59o- 86o F)
  • protect from heat and moisture

Inactive ingredients

D&C yellow #10, edible ink, FD&C Blue#1, FD&C Red#40, gelatin, glycerin, peppermint oil, purified water, sorbitol special, and titanium dioxide

Questions or Comments?

1-800-616-2471

Principal Display Panel

 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®

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Extra Strength Gas-X®

Distributed by:

Major® Pharmaceuticals

31778 Enterprise Drive

Livonia MI 48150 USA

EACH DOSE IS INDIVIDUALLY SEALED IN A BLISTER PACK. DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

Major Pharmaceuticals

Simethicone 125 mg softgels

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: 02/2013
Document Id: 5c251b09-f330-4c6e-ad8f-0322912be09a
Set id: 7ee40638-84b7-4c19-9bd1-151bcaff61ed
Version: 2
Effective Time: 20130205
 
Major Pharmaceuticals

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