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Mi-Acid Gas Relief by Aphena Pharma Solutions - Tennessee, LLC

Dosage form: tablet, chewable
Ingredients: SIMETHICONE 80mg
Labeler: Aphena Pharma Solutions - Tennessee, LLC
NDC Code: 43353-325

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Mi-Acid Gas Relief

Active ingredient (in each tablet)

Simethicone 80 mg

Purpose

Antigas

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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:

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:

Cookeville, TN 38506

20171030JH

PRINCIPAL DISPLAY PANEL - 80mg

NDC 43353-325 Simethicone 80mg - Rx Only

MI-ACID GAS RELIEF 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43353-325(NDC:0904-5068)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
SUCROSE 
DEXTROSE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
SORBITOL 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize13mm
FlavorPEPPERMINTImprint CodeGDC103
Contains    
Packaging
#Item CodePackage Description
1NDC:43353-325-044 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33203/02/2011
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIOperations
Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(43353-325)

 
Aphena Pharma Solutions - Tennessee, LLC

← See all Mi-Acid Gas Relief brands

Medically reviewed on Oct 30, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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