Mi-Acid Gas Relief

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
Effective date
2017-10-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:10:43

Label at a glance#

ProductMi-Acid Gas Relief
Active ingredientDIMETHICONE
Label structure11 sections

Indications and uses

relieves: pressure bloating symptoms referred to as gas

Dosage and administration

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.

Storage and handling

do not use if inner seal is broken. store at room temperature avoid high humidity and excessive heat, above 40 0 C (104 0 F)

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 80 mg

Purpose

OTC - PURPOSE SECTION

Antigas

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Enter section text here

Uses

INDICATIONS & USAGE SECTION

relieves:

  • pressure
  • bloating
  • symptoms referred to as gas

Warnings

WARNINGS SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • do not use if inner seal is broken.
  • store at room temperature
  • avoid high humidity and excessive heat, above 400C (1040F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions

OTC - QUESTIONS SECTION

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

Repackaging Information

SPL UNCLASSIFIED SECTION

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:

Count80 mg
443353-325-04

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:
Aphena Pharma Solutions - TNAphena Pharma Solutions - TN
Cookeville, TN 38506

20171030JH

PRINCIPAL DISPLAY PANEL - 80mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 43353-325 Simethicone 80mg - Rx Only
Bottle Label 80mgBottle Label 80mg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-325MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20171102_f278e9ee-0c9e-495a-a916-ee9ffa8f9967.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5068-60EA - Each0904-50686f3055e0-6cdc-44ea-9134-ca80b5c7bb0612013-02-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43353-32543353-325-04
0904-5068

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
36ea951e-40b5-5fca-e063-6394a90af9fcf278e9ee-0c9e-495a-a916-ee9ffa8f99672025-06-06WarningsExact identifier
spl set id: f278e9ee-0c9e-495a-a916-ee9ffa8f9967

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.