MAJOR ULTRA STRENGTH GAS RELIEF- simethicone 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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Drug Facts

Active ingredient (in each softgel)

Simethicone 180 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 professional before use.

Keep out of reach of children.

Directions

  • swallow one or two softgels as needed after a meal
  • do not exceed two softgels per day except under the advice and supervision of a physician

Other information

  • store at 15º-30ºC (59º-86ºF)

Inactive ingredients

edible ink, FD&C yellow #6, gelatin, glycerin, purified water

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Ultra Strength GAS RELIEF

Antiflatulent

Simethicone 180 mg

Relieves Bloating, Pressure, Fullness & Gas

Compare to the active ingredient of PHAZYME® ULTRA STRENGTH*

Softgels

*This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme®.

Distributed by:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive,Suite 233

Livonia, MI 48152

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

Simethicone 180 mg

Major Ultra Strength Gas Relief

MAJOR ULTRA STRENGTH GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5572
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize12mm
FlavorImprint Code S180
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-5572-5260 in 1 BOTTLE; Type 0: Not a Combination Product07/12/201007/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33207/12/201007/28/2023
Labeler - Major Pharmaceuticals (191427277)

Revised: 12/2022
Document Id: 612bb207-fb5c-4f13-b19d-0959ec181751
Set id: f4f64a21-98ae-410d-add2-8eb3e6be2302
Version: 13
Effective Time: 20221216
 
Major Pharmaceuticals