MI-ACID GAS RELIEF- simethicone tablet, chewable 
Aphena Pharma Solutions - Tennessee, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Mi-Acid Gas Relief

Active ingredient (in each tablet)

Simethicone 80 mg

Purpose

Antigas

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 40 0C (104 0F)

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 Suppliedsection 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 - TN
Cookeville, TN 38506

20171030JH

PRINCIPAL DISPLAY PANEL - 80mg

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

MI-ACID GAS RELIEF 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43353-325(NDC:0904-5068)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
DEXTROSE (UNII: IY9XDZ35W2)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize13mm
FlavorPEPPERMINTImprint Code GDC103
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43353-325-044 in 1 BOTTLE; Type 0: Not a Combination Product05/11/201708/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/02/201108/31/2021
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Tennessee, LLC128385585repack(43353-325)

Revised: 6/2025
 
Aphena Pharma Solutions - Tennessee, LLC