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  5. Label Information: Mi-acid Gas Relief

FDA Label for Mi-acid Gas Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. OTC - KEEP OUT OF REACH OF CHILDREN
    4. USES
    5. WARNINGS
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS
    10. REPACKAGING INFORMATION
    11. PRINCIPAL DISPLAY PANEL - 80MG

Mi-acid Gas Relief Product Label

The following document was submitted to the FDA by the labeler of this product Aphena Pharma Solutions - Tennessee, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Tablet)



Simethicone 80 mg


Purpose



Antigas


Otc - Keep Out Of Reach Of Children



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:

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 - Aphena

Aphena Pharma Solutions - TN - Aphena


Cookeville, TN 38506

20171030JH


Principal Display Panel - 80Mg



NDC 43353-325 Simethicone 80mg - Rx Only

Bottle Label 80mg - 43353 325

Bottle Label 80mg - 43353 325


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