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NDC 00904-7206-60 Antiflatulent 80 mg/1 Details

Antiflatulent 80 mg/1

Antiflatulent is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. 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: 00904-7206-60
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	00904-7206
Product ID	0904-7206_019a85b2-f07a-4f5d-ae1f-4473fc4fe267
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	Antiflatulent
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	Major Pharmaceuticals
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 00904-7206-60 (00904720660)

Pricing Information
NDC Package Code	0904-7206-60
Billing NDC	00904720660
Package	100 TABLET, CHEWABLE in 1 BOTTLE (0904-7206-60)
Marketing Start Date	2021-10-04
NDC Exclude Flag	N
Price Per Unit	0.02838
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	SIMETHICONE 80 MG TAB 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 d321114e-09ac-4252-a6e6-3dbc3a451ee6 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 (1-800-222-1222) 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.

QUESTIONS

Call (800) 616-2471

PRINCIPAL DISPLAY PANEL

NDC 0904-7206-60

MAJOR

Simethicone 80 mg

Antiflatulent

Relieves gas pain, pressure and bloating

100 Chewable Tablets

INGREDIENTS AND APPEARANCE

ANTIFLATULENT

simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-7206
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	G;103
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-7206-60	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/04/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part332	10/04/2021

Labeler - Major Pharmaceuticals (191427277)

Name	Address	ID/FEI	Business Operations
Establishment
Guardian Drug Company		119210276	MANUFACTURE(0904-7206)

Revised: 1/2022

Document Id: 019a85b2-f07a-4f5d-ae1f-4473fc4fe267

Set id: d321114e-09ac-4252-a6e6-3dbc3a451ee6

Version: 3

Effective Time: 20220105