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NDC 70000-0434-01 Leader Gas relief 80 mg/1 Details

Leader Gas relief 80 mg/1

Leader Gas relief is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by CARDINAL HEALTH 110, LLC. DBA LEADER. 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: 70000-0434-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	70000-0434
Product ID	70000-0434_45569495-dac6-44ea-b3bb-f3f18000e734
Associated GPIs	52200020000510
GCN Sequence Number	002821
GCN Sequence Number Description	simethicone TAB CHEW 80 MG ORAL
HIC3	D4N
HIC3 Description	ANTIFLATULENTS
GCN	08281
HICL Sequence Number	001224
HICL Sequence Number Description	SIMETHICONE
Brand/Generic	Generic
Proprietary Name	Leader Gas relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Simethicone
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	80
Active Ingredient Units	mg/1
Substance Name	DIMETHICONE
Labeler Name	CARDINAL HEALTH 110, LLC. DBA LEADER
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part332
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0434-01 (70000043401)

Pricing Information
NDC Package Code	70000-0434-1
Billing NDC	70000043401
Package	100 TABLET, CHEWABLE in 1 BOTTLE (70000-0434-1)
Marketing Start Date	2019-06-07
NDC Exclude Flag	N
Price Per Unit	0.02838
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	GAS RELIEF (SIMETH) 80 MG CHEW
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

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 0163d372-222e-4a8d-a5cb-5a7af9a7068c Details

ACTIVE INGREDIENT(in each tablet)

Simethicone 80 mg

PURPOSE

Antigas

USE(S)

relieves:

pressure
bloating
symptoms referred to as gas

WARNINGS

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center immediately.

DIRECTIONS

chew 2 to 4 tablets thoroughly as needed after meals and at bedtime
do not exceed 6 tablets per day unless directed by a physician

OTHER INFORMATION

do not use if inner seal is broken
store at room temperature
avoid high humidity and excessive heat, above 40oC (104oF)

INACTIVE INGREDIENTS

compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.

PRINCIPAL DISPLAY PANEL

NDC 70000-0434-1

LEADER™

Gas Relief

Simethicone, 80 mg

Antigas

Mint Flavor

For Relief of :

Pressure, Bloating, Symptoms Referred to as Gas

100 CHEWABLE TABLETS

INGREDIENTS AND APPEARANCE

LEADER GAS RELIEF

simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0434
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	80 mg

Ingredient Name	Strength
Inactive Ingredients
SUGARCANE (UNII: 81H2R5AOH3)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	13mm
Flavor	PEPPERMINT	Imprint Code	G103
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0434-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/07/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part332	06/07/2019

Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)

Name	Address	ID/FEI	Business Operations
Establishment
Guardian Drug Company		119210276	MANUFACTURE(70000-0434)

Revised: 1/2022

Document Id: 45569495-dac6-44ea-b3bb-f3f18000e734

Set id: 0163d372-222e-4a8d-a5cb-5a7af9a7068c

Version: 3

Effective Time: 20220110