GAS RELIEF EXTRA STRENGTH- dimethicone capsule, liquid filled 
BJWC (Berkley & Jensen / BJ's)

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)

Use

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

  • store at controlled room temperature 15°-30°C (59°-86°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?

call toll free: 1-800-934-1204 Monday-Friday 9AM-5PM EST

Principal Display Panel

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

Extra Strength

Gas Relief

Simethicone, 125 mg

Relieves:

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

DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

Berkley & Jensen extra strength Gas Relief softgels

Simethicone 125 mg

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68391-550
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)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color GREEN Score no score
Shape OVAL Size 9mm
Flavor Imprint Code PO
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68391-550-12 8 in 1 CARTON
1 15 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part332 07/15/2013
Labeler - BJWC (Berkley & Jensen / BJ's) (159082692)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 1/2013
Document Id: ad83cde8-345a-4e36-8c32-e25b56f5631d
Set id: b64e4438-27ef-410a-95f7-6bad9a13129f
Version: 1
Effective Time: 20130121
 
BJWC (Berkley & Jensen / BJ's)