MAJOR Extra Strength Gas Relief

Dosage form: capsule, liquid filled
Ingredients: DIMETHICONE 125mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-5458

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.

Drug Facts

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

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 CodePO
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5458-4630 CAPSULE, LIQUID FILLED (30 CAPSULE) 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
 
Major Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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