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NDC 49348-0073-09 gas relief 125 mg/1 Details

gas relief 125 mg/1

gas relief is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services, LLC (Sunmark). The primary component is DIMETHICONE.

MedlinePlus Drug Summary

Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 49348-0073-09
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	49348-0073
Product ID	49348-073_0be0a7c0-e386-47d1-8eb8-3f1bf4d03b5d
Associated GPIs	52200020000120
GCN Sequence Number	002814
GCN Sequence Number Description	simethicone CAPSULE 125 MG ORAL
HIC3	D4N
HIC3 Description	ANTIFLATULENTS
GCN	09270
HICL Sequence Number	001224
HICL Sequence Number Description	SIMETHICONE
Brand/Generic	Generic
Proprietary Name	gas relief
Proprietary Name Suffix	Extra Strength
Non-Proprietary Name	Simethicone
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	125
Active Ingredient Units	mg/1
Substance Name	DIMETHICONE
Labeler Name	Strategic Sourcing Services, LLC (Sunmark)
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part332
Listing Certified Through	2023-12-31

Package

Package Images

NDC 49348-0073-09 (49348007309)

Pricing Information
NDC Package Code	49348-073-09
Billing NDC	49348007309
Package	5 BLISTER PACK in 1 CARTON (49348-073-09) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date	2015-03-01
NDC Exclude Flag	N
Price Per Unit	0.072
Pricing Unit	EA
Effective Date	2022-08-17
NDC Description	SM GAS RELIEF 125 MG SOFTGEL
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2022-08-17

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 66e393f3-55bf-4855-9fd3-ca647cafb3c2 Details

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: 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 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, edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

sunmark®

COMPARE TO

GAS-X® EXTRA STRENGTH

ACTIVE INGREDIENT*

NDC 49348-073-09

Extra Strength

gas relief

SIMETHICONE 125 mg

Antigas

relieves

pressure

bloating

discomfort

actual

size

EASY TO SWALLOW

50 SOFTGELS

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 GSK Consumer Healthcare S.A.,

owner of the registered trademark Gas-X® Extra Strength.

50844 REV0419A66415

Product of China

Packaged and Quality Assured in the USA

MCKESSON

Distributed by McKesson Corporation

6555 State Highway 161

Irving, TX 75039

www.mckesson.com

SunMark 44-664

INGREDIENTS AND APPEARANCE

GAS RELIEF EXTRA STRENGTH

simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49348-073
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)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	9mm
Flavor		Imprint Code	664
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49348-073-09	5 in 1 CARTON	03/01/2015
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	03/01/2015

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

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(49348-073)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(49348-073)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(49348-073)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(49348-073)

Revised: 5/2022

Document Id: 0be0a7c0-e386-47d1-8eb8-3f1bf4d03b5d

Set id: 66e393f3-55bf-4855-9fd3-ca647cafb3c2

Version: 7

Effective Time: 20220509