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

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.

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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

GAS RELIEF
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70677-0111
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	green (opaque)	Score	no score
Shape	OVAL	Size	9mm
Flavor		Imprint Code	753
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 70677-0111-1	5 in 1 CARTON	08/05/2020	10/11/2022
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	08/05/2020	10/11/2022

Labeler - Strategic Sourcing Services, LLC (Sunmark) (116956644)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(70677-0111)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(70677-0111)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(70677-0111)

Revised: 10/2022

Document Id: 25f28406-7d05-4819-8fe7-1fc7c33f38ff

Set id: 0a534705-5c12-4870-b0b9-aed705dff86e

Version: 3

Effective Time: 20221011

Trademark Results [gas relief]

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