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NDC 43353-0325-04 Mi-Acid Gas Relief 80 mg/1 Details

Mi-Acid Gas Relief 80 mg/1

Mi-Acid Gas Relief is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. 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: 43353-0325-04
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	43353-0325
Product ID	43353-325_5fa3f583-8654-4f38-8014-34b792086809
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	Mi-Acid 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	Aphena Pharma Solutions - Tennessee, LLC
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 43353-0325-04 (43353032504)

Pricing Information	N/A
NDC Package Code	43353-325-04
Billing NDC	43353032504
Package	4 TABLET, CHEWABLE in 1 BOTTLE (43353-325-04)
Marketing Start Date	2017-05-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f278e9ee-0c9e-495a-a916-ee9ffa8f9967 Details

Active ingredient (in each tablet)

Simethicone 80 mg

Purpose

Antigas

SPL UNCLASSIFIED SECTION

Enter section text here

Uses

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 400C (1040F)

Inactive ingredients

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

Questions

To Report Adverse Drug Event Call: (800) 616-2471

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count	80 mg
4	43353-325-04

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506

20171030JH

PRINCIPAL DISPLAY PANEL - 80mg

NDC 43353-325 Simethicone 80mg - Rx Only

INGREDIENTS AND APPEARANCE

MI-ACID GAS RELIEF

simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43353-325(NDC:0904-5068)
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
SUCROSE (UNII: C151H8M554)
DEXTROSE (UNII: IY9XDZ35W2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	13mm
Flavor	PEPPERMINT	Imprint Code	GDC103
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43353-325-04	4 in 1 BOTTLE; Type 0: Not a Combination Product	05/11/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	03/02/2011

Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)

Name	Address	ID/FEI	Business Operations
Establishment
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(43353-325)

Revised: 10/2017

Document Id: 5fa3f583-8654-4f38-8014-34b792086809

Set id: f278e9ee-0c9e-495a-a916-ee9ffa8f9967

Version: 1

Effective Time: 20171030