gas relief by Strategic Sourcing Services, LLC (Sunmark) / LNK International, Inc. Sunmark 44-753-Delisted

gas relief by

Drug Labeling and Warnings

gas relief by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services, LLC (Sunmark), LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GAS RELIEF- simethicone capsule, liquid filled 
Strategic Sourcing Services, LLC (Sunmark)

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.

----------

Sunmark 44-753-Delisted

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 date 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

sunmark®

COMPARE TO
GAS-X® EXTRA STRENGTH
ACTIVE INGREDIENT*

NDC: 70677-0111-1

Extra Strength
gas relief
SIMETHICONE 125 mg
Antigas

relieves
pressure
bloating
discomfort

EASY TO SWALLOW

actual
size

50 SOFTGELS

*This product is not manufactured or distributed by GSK Consumer Healthcare S.A.,
owner of the registered trademark Gas-X® Extra Strength.
50844     ORG022075315

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

Product of Dubai
Packaged and Quality Assured in the USA

Distributed by McKesson Corporation
6555 State Highway 161
Irving, TX 75039
www.mckesson.com

Sunmark 44-753

Sunmark 44-753

GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70677-0111
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, UNSPECIFIED (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
Colorgreen (opaque) Scoreno score
ShapeOVALSize9mm
FlavorImprint Code 753
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70677-0111-15 in 1 CARTON08/05/202010/11/2022
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 finalpart33208/05/202010/11/2022
Labeler - Strategic Sourcing Services, LLC (Sunmark) (116956644)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(70677-0111)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837pack(70677-0111)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(70677-0111)

Revised: 10/2022
 
St

Trademark Results [gas relief]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GAS RELIEF
GAS RELIEF
85443589 not registered Dead/Abandoned
Traditional Medicinals
2011-10-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.