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Gas Relief Extra Strength by Major Pharmaceuticals

Medically reviewed on November 14, 2017

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 125mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-6606

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.

Major 44-664

Active ingredient (in each liquid-filled capsule)

Simethicone 125 mg

Purpose

Antigas

Use

relieves bloating, pressure, fullness, or stuffed feeling commonly referred to as gas

Warnings

Keep out of reach of children.

Directions
  • adults: swallow with water 1 or 2 capsules as needed after meals and at bedtime
  • do not exceed 4 capsules in 24 hours unless directed by a doctor

Other information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • ​store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from light, heat and moisture
  • see end flap for expiration date and lot number 

Inactive ingredients

D&C yellow #10, edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, lecithin, mineral oil, peppermint oil,
purified water, titanium dioxide

Questions or comments?

(800)-616-2471

Principal display panel

Major®

NDC 0904-6606-36

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

Extra Strength
  Gas Relief 

Simethicone 125 mg
Antigas

Relieves:
Pressure
Bloating
Discomfort

Easy to Swallow

30 Softgels

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING 

Distibuted by MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA
Re-order No. 700831
M-17       Rev. 10/16

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

50844    ORG121566401

Product of China
Packaged and Quality Assured in the USA

Major 44-664

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6606
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
MINERAL OIL 
PEPPERMINT OIL 
TITANIUM DIOXIDE 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize9mm
FlavorImprint Code664
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-6606-362 BLISTER PACK in 1 CARTON
115 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33203/01/2015
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIOperations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd421293287API MANUFACTURE(0904-6606)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(0904-6606)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(0904-6606)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(0904-6606)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(0904-6606)

 
Major Pharmaceuticals

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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