GAS RELIEF- simethicone capsule, liquid filled 
L.N.K. International, Inc.

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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Quality Plus 44-753

Active ingredient (in each liquid-filled capsule)

Simethicone 125 mg

Purpose

Antigas

Uses

for the relief of pressure, bloating, and fullness commonly referred to as gas

Warnings

Keep out of reach of children.

Directions

  • adults and children 12 years and over: 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
  • children under 12 years: ask a doctor

Other information

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

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal display panel

QUALITY PLUS

NDC 50844-795-32

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

EXTRA STRENGTH
GAS RELIEF
Simethicone 125 mg
ANTIGAS

Relieves:
• Pressure • Bloating • Discomfort

Easy to Swallow

120 Liquid-filled capsules

ACTUAL SIZE

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

*This product is not manufactured or distributed by GSK Consumer Healthcare S.A., owner of the registered trademark Gas-X® Extra Strength.
50844      ORG022075332

Distributed by LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA

Product of Dubai
Packaged and
Quality Assured in
the USA

Quality Plus 44-753

Quality Plus 44-753

GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-795
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)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize9mm
FlavorImprint Code 753
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50844-795-29150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/06/2021
2NDC:50844-795-328 in 1 CARTON05/06/2021
215 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33205/06/2021
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837pack(50844-795)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(50844-795)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(50844-795)

Revised: 10/2021
Document Id: 9eba620e-109d-4e83-a726-bf83dd772be6
Set id: 9bd09a17-2ec5-4a64-9ccd-657f6c585494
Version: 2
Effective Time: 20211020
 
L.N.K. International, Inc.