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  5. Label Information: Antiflatulent

FDA Label for Antiflatulent

View Indications, Usage & Precautions

Table of Contents

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

Antiflatulent 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


Use(S)



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 (1-800-222-1222) 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 40oC (104oF)

How Supplied



Simethicone Chewable Tablets, 80 mg are white, round, tablets, debossed with "G" on one side and "103" on the other side and are supplied as:

NDC 0904-7206-60 in bottle of 100 chewable tablets

Distributed by:

Major Pharmaceuticals

Livonia, MI 48152


Inactive Ingredients



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


Questions



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
471610-650-04

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

20220519JK


Principal Display Panel - 80 Mg



NDC 71610-650 - Simethicone 80 mg Chewable Tablet - Rx Only

Bottle Label 80 mg - 71610 0650 04

Bottle Label 80 mg - 71610 0650 04


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