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NDC 70518-3325-01 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 REMEDYREPACK INC.. 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: 70518-3325-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	70518-3325
Product ID	70518-3325_e9bf699c-13b9-6595-e053-2a95a90a3b73
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
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	REMEDYREPACK INC.
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 70518-3325-01 (70518332501)

Pricing Information	N/A
NDC Package Code	70518-3325-1
Billing NDC	70518332501
Package	100 POUCH in 1 BOX (70518-3325-1) / 1 TABLET, CHEWABLE in 1 POUCH (70518-3325-2)
Marketing Start Date	2022-03-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e3a218f5-d1fa-418e-987a-58aa811f94e0 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 40 oC (104 oF)

INACTIVE INGREDIENTS

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

PRINCIPAL DISPLAY PANEL

DRUG: Leader Gas relief

GENERIC: Simethicone

DOSAGE: TABLET, CHEWABLE

ADMINSTRATION: ORAL

NDC: 70518-3325-0

NDC: 70518-3325-1

NDC: 70518-3325-2

COLOR: white

FLAVOR: PEPPERMINT

SHAPE: ROUND

SCORE: No score

SIZE: 13 mm

IMPRINT: G103

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

ACTIVE INGREDIENT(S):

DIMETHICONE 80mg in 1

INACTIVE INGREDIENT(S):

SUGARCANE
MALTODEXTRIN
DEXTROSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SORBITOL

INGREDIENTS AND APPEARANCE

LEADER GAS RELIEF

simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70518-3325(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
Packaging
1	NDC:70518-3325-0	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	01/04/2022
2	NDC:70518-3325-1	100 in 1 BOX	03/09/2022
2	NDC:70518-3325-2	1 in 1 POUCH; 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	01/04/2022

Labeler - REMEDYREPACK INC. (829572556)

Revised: 9/2022

Document Id: e9bf699c-13b9-6595-e053-2a95a90a3b73

Set id: e3a218f5-d1fa-418e-987a-58aa811f94e0

Version: 4

Effective Time: 20220928