GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled 
Chain Drug Consortium

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.

----------

Premier Value 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 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?

1-800-426-9391

Principal Display Panel

Premier
Value®

NDC 68016-643-30

*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 Liquid-filled
Capsules

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

*This product is not manufactured or distributed by Novartis Consumer Health, Inc.,
owner of the registered trademark Gas-X® Extra Strength.
50844               ORG091466401

Product of China
Packaged and Quality Assured in the USA

DISTRIBUTED BY
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL  33431

If for any reason you are not satisfied with
this product, please return it to the store
where purchased for a full refund.

Premier Value 44-664

Premier Value 44-664

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-643
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
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)  
MINERAL OIL (UNII: T5L8T28FGP)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize9mm
FlavorImprint Code 664
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-643-303 in 1 CARTON03/01/201502/04/2023
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33203/01/201502/04/2023
Labeler - Chain Drug Consortium (101668460)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(68016-643)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(68016-643)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(68016-643)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(68016-643)

Revised: 5/2020
Document Id: 5ad87260-57d4-4ed7-a19d-2a426074b0ad
Set id: 2fd420ab-d3ce-4ce6-806c-2da4bec3e2f6
Version: 6
Effective Time: 20200519
 
Chain Drug Consortium