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.

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Drug Facts

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antiflatulent (Antigas)

Uses

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

Other information

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:

*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 Type HUMAN OTC DRUG Item Code (Source) NDC:0904-5458
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 125 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color GREEN Score no score
Shape OVAL Size 10mm
Flavor Imprint Code PO
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0904-5458-46 30 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part332 09/16/1998
Labeler - Major Pharmaceuticals (191427277)

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